FDA records document recurring safety concerns involving reusable endoscopes, including contamination after reprocessing, component detachment, tissue damage, bleeding, perforation, respiratory distress, and infection.
Schmidt & Clark currently screens certain claims involving qualifying endoscopic procedures performed from 2018 to the present. Eligibility depends on the procedure, medical complication, device involved, timing, causation evidence, damages, and applicable law.
Quick Facts
- Endoscopic procedures use specialized scopes to examine or treat internal organs and body cavities.
- Potential injuries include perforation, tissue damage, device breakage, hemorrhage, sepsis, bacteremia, serious infection, and death.
- FDA has documented contamination, reprocessing, detachment, and tissue-injury concerns involving certain reusable endoscopic devices.
- Current Schmidt & Clark screening criteria include specified procedures performed from 2018 to the present and serious documented complications.
Table Of Contents
- Latest Endoscopic Procedure Safety and Lawsuit Developments
- What Are Endoscopic Procedures?
- Which Endoscopic Procedures Are Currently Being Screened?
- What Injuries May Be Associated With Endoscopic Procedures?
- How Can an Endoscope Cause Perforation?
- What Happens If an Endoscopic Device Breaks or Detaches?
- When Can Hemorrhaging Become a Serious Endoscopy Injury?
- Why Can Reusable Endoscopes Transmit Infection?
- What Is Endoscope Reprocessing?
- Why Do Automated Endoscope Reprocessor Recalls Matter?
- What Is Sepsis or Bacteremia?
- Which Drug-Resistant Infections Are a Concern?
- Can Bronchoscopy Lead to Pulmonary Infection?
- What Types of Endoscopes Are Used in These Procedures?
- How Do I Find Out Which Endoscope Was Used?
- Who May Be Affected?
- Who May Be Liable for an Endoscopy Injury?
- Do I Qualify?
- What Evidence Should I Preserve?
- Do I Have an Endoscopic Procedures Lawsuit?
- Important Legal Actions or Recalls
- Potential Compensation
- Legal Process Overview
- Frequently Asked Questions About Endoscopic Procedures
- Do I Have an Endoscopic Procedures Lawsuit?
- What Evidence May Support an Endoscopic Procedures Lawsuit?
- Which Procedures Are Currently Included?
- Can an Endoscope Cause a Perforation?
- Can a Reusable Endoscope Transmit Infection?
- What Infections Are Currently Being Screened?
- What If Part of the Scope Broke Inside Me?
- How Can I Identify the Scope Used During My Procedure?
- References
Latest Endoscopic Procedure Safety and Lawsuit Developments
July 2026
- July 7, 2026 – FDA posted an open Class II recall involving Olympus Single Use Distal Cover MAJ-2315, an accessory used with the EVIS EXERA III TJF-Q190V duodenoscope. FDA identified device design as the cause, and Olympus instructed customers to remove the previous distal-cover design from inventory [1]
March 2026
- March 20, 2026 – FDA classified recalls involving Olympus OER-Pro and OER-Elite automated endoscope reprocessors because MAJ-1443 and MAJ-1444 valves were no longer considered compatible with those systems. FDA identified reprocessing controls as the cause [2]
November 2025
- November 21, 2025 – FDA posted a recall involving the Olympus TJF-Q190V duodenoscope after continued reports of positive cultures and infections prompted updated reprocessing materials intended to minimize cleaning and disinfection deviations [3]
February 2024
- February 9, 2024 – FDA posted a recall involving Olympus MAJ-2315 distal covers because they could unexpectedly detach during endoscopic procedures, potentially causing tissue damage, bleeding, perforation, obstruction, aspiration, airway obstruction, or respiratory distress [4]
What Are Endoscopic Procedures?
Endoscopic procedures use a specialized instrument containing a camera or optical system to examine internal organs, passageways, or body cavities.
Many procedures use flexible scopes passed through the mouth, rectum, urinary tract, nose, or another natural opening. Others use rigid or flexible instruments inserted through small surgical incisions.
Physicians may use endoscopy for diagnosis, biopsy, removal of tissue or stones, treatment of bleeding, placement of stents, surgery, and other medical interventions.
Which Endoscopic Procedures Are Currently Being Screened?
For current Schmidt & Clark case screening, the patient must have undergone at least one qualifying endoscopic procedure from 2018 to the present.
- Laparoscopy
- Colonoscopy
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Bronchoscopy
- Upper endoscopy
- Ureteroscopy
- Hysteroscopy
- Sinus endoscopy
- Cystoscopy
These are Schmidt & Clark’s current screening criteria rather than FDA eligibility standards. Undergoing one of these procedures does not establish that malpractice, a defective device, or another actionable problem occurred.
What Injuries May Be Associated With Endoscopic Procedures?
Current case screening focuses on significant medical complications rather than temporary discomfort or expected post-procedure symptoms.
Potentially qualifying injuries include:
- Organ or tissue damage, including perforation
- Breaking, detachment, or dislodging of an endoscopic device or component
- Serious procedure-related hemorrhage
- Death resulting from infection or component failure
- Sepsis or bacteremia
- Bacterial infection requiring hospitalization within 90 days
- Pneumonia or another severe pulmonary infection within 90 days
- Tuberculosis diagnosed within 90 days
- HIV diagnosed within 90 days
- A drug-resistant infection such as CRE or resistant E. coli diagnosed within 180 days
The timing requirements above are Schmidt & Clark screening parameters, not proof that an endoscope caused an infection or other injury.
How Can an Endoscope Cause Perforation?
A perforation occurs when an instrument tears or punctures the wall of an organ or other internal tissue.
Perforation can occur during endoscopy without a product defect, but a claim may warrant investigation when the injury coincides with device malfunction, unexpected component movement, breakage, detachment, or another suspected equipment problem.
FDA has documented mucosal injury and perforation risks involving certain Olympus duodenoscope distal covers [5]
What Happens If an Endoscopic Device Breaks or Detaches?
An endoscope can include mechanical components, accessories, caps, valves, channels, and treatment instruments used during a procedure.
A detached component may remain inside the patient and require retrieval through another endoscopic procedure or surgery.
FDA has reported that detachment of certain Olympus distal covers could result in mucosal injury, tissue damage, bleeding, perforation, gastrointestinal obstruction, aspiration, airway obstruction, or respiratory distress.
When Can Hemorrhaging Become a Serious Endoscopy Injury?
Some bleeding may be expected following biopsies or other therapeutic procedures, but substantial hemorrhage can require emergency treatment.
Schmidt & Clark currently screens procedure-related hemorrhage claims when bleeding resulted in an unplanned or prolonged hospital stay, blood transfusion, or another significant medical intervention associated with pain and suffering.
Relevant evidence may include operative reports, transfusion records, repeat procedures, imaging, laboratory results, and hospitalization records.
Why Can Reusable Endoscopes Transmit Infection?
Reusable scopes contain internal channels, valves, joints, and other components that can retain biological material if cleaning and disinfection are incomplete.
Microorganisms that remain inside a device may potentially be introduced into another patient during a subsequent procedure.
FDA has investigated infections associated with reprocessed duodenoscopes even when medical facilities reported following manufacturer cleaning and disinfection instructions [6]
What Is Endoscope Reprocessing?
Reprocessing is the multistep cleaning and disinfection or sterilization process performed before a reusable medical device is used again.
Depending on the device, steps may include bedside pre-cleaning, leak testing, manual brushing, flushing, high-level disinfection, rinsing, drying, inspection, and storage.
Problems during any stage may potentially allow contamination to remain within the scope or its accessories.
Why Do Automated Endoscope Reprocessor Recalls Matter?
Some medical facilities use automated endoscope reprocessors to perform high-level disinfection after manual cleaning.
FDA’s 2026 Olympus OER-Pro and OER-Elite actions involved valves that were no longer considered compatible with those reprocessing systems. Facilities were instructed to stop processing the affected valves through those machines and follow updated instructions.
In an infection investigation, the endoscope, valves, reprocessing equipment, cleaning records, maintenance history, staff practices, and storage conditions may all become relevant.
What Is Sepsis or Bacteremia?
Bacteremia means bacteria are present in the bloodstream. Sepsis is a potentially life-threatening response to infection that can result in organ dysfunction.
Both are included in Schmidt & Clark’s current case-screening criteria for serious complications following qualifying endoscopic procedures.
Blood cultures, antibiotic records, infectious-disease evaluations, ICU records, and discharge documentation can help establish the diagnosis and severity.
Which Drug-Resistant Infections Are a Concern?
Reusable scope investigations have included organisms resistant to important antibiotics, including carbapenem-resistant Enterobacteriaceae, commonly called CRE.
Current Schmidt & Clark screening criteria also include drug-resistant infections such as CRE or resistant E. coli diagnosed within 180 days of a qualifying procedure.
Culture results and antimicrobial-susceptibility testing can be especially important when determining the organism involved.
Can Bronchoscopy Lead to Pulmonary Infection?
Bronchoscopy involves passing a scope into the airways to examine or treat the lungs and respiratory tract.
A post-procedure pneumonia or severe pulmonary infection can have several possible causes, including underlying illness, aspiration, or microbial exposure.
Current screening includes pneumonia and severe pulmonary infections diagnosed within 90 days, but timing alone does not establish that a bronchoscope transmitted the infection.
What Types of Endoscopes Are Used in These Procedures?
The device used depends on the area of the body being examined or treated.
A colonoscope is used for colonoscopy, a bronchoscope examines the airways, a duodenoscope is commonly used during ERCP, a cystoscope examines the bladder, and a ureteroscope is used within the urinary tract.
Hysteroscopes examine the uterus, while sinus endoscopes allow visualization and treatment inside the nasal and sinus cavities.
How Do I Find Out Which Endoscope Was Used?
Patients can request complete medical records from the hospital, surgery center, clinic, or physician that performed the procedure.
Procedure notes, operating-room records, device logs, nursing documentation, billing records, scope-tracking systems, and reprocessing records may identify the manufacturer, model, and serial number.
Device identification can be important when determining whether the scope or component was subject to a recall or safety correction.
Who May Be Affected?
Potentially affected patients include people who underwent one of the qualifying procedures from 2018 to the present and suffered a serious complication included in Schmidt & Clark’s current screening criteria.
Families may also warrant legal review when an infection, perforation, component failure, or another serious event resulted in death.
Meeting screening criteria does not establish that a viable lawsuit exists.
Who May Be Liable for an Endoscopy Injury?
Potentially responsible parties may include a medical-device manufacturer, component manufacturer, distributor, hospital, surgical facility, reprocessing provider, maintenance company, or another entity depending on what caused the injury.
Potential claims may involve defective design, manufacturing defects, inadequate warnings, component failure, improper maintenance, negligent reprocessing, or other theories available under applicable law.
A recall, adverse event, or post-procedure infection does not automatically establish liability. Evidence must address product or provider involvement, causation, injury, and damages.
Do I Qualify?
- Did you undergo laparoscopy, colonoscopy, ERCP, bronchoscopy, upper endoscopy, ureteroscopy, hysteroscopy, sinus endoscopy, or cystoscopy from 2018 to the present?
- Did you suffer perforation, organ or tissue damage, device breakage, significant hemorrhage, sepsis, bacteremia, or death from infection or component failure?
- Were you hospitalized with a qualifying infection within 90 days or diagnosed with a qualifying drug-resistant infection within 180 days?
- Do you have procedure records, culture results, imaging, hospitalization records, or device-identification evidence documenting what occurred?
Schmidt & Clark can review whether the procedure, injury, timing, device information, causation evidence, damages, and applicable filing deadlines meet the firm’s current case criteria.
What Evidence Should I Preserve?
Request and preserve the procedure report, operative report, anesthesia records, hospital records, imaging, laboratory testing, pathology, transfusion records, culture results, and discharge documentation.
For infection claims, preserve organism-identification and antimicrobial-susceptibility results, infectious-disease consultations, antibiotic records, and evidence showing when symptoms began.
Device evidence may include manufacturer and model information, serial numbers, scope-tracking logs, repair records, reprocessing logs, incident reports, photographs, and recovered device components.
Do I Have an Endoscopic Procedures Lawsuit?
If you or a loved one suffered a serious injury after a qualifying endoscopic procedure, you may have legal options. Contact Schmidt & Clark for a free case review.
Important Legal Actions or Recalls
| Event | Month/Year | Type | Status | Source | Notes |
|---|---|---|---|---|---|
| Olympus MAJ-2315 distal cover recall | July 2026 | Class II recall | Open | FDA | Device design issue |
| Olympus endoscope reprocessor recalls | March 2026 | Class II recalls | Open | FDA | Reprocessing controls |
| TJF-Q190V duodenoscope recall | November 2025 | Class II recall | Open | FDA | Positive cultures reported |
| MAJ-2315 detachment recall | February 2024 | Class II recall | FDA action | FDA | Detachment and injury risk |
Potential Compensation
Potential compensation may include emergency care, hospitalization, surgery, blood transfusions, infection treatment, antibiotics, rehabilitation, additional procedures, and future medical expenses supported by the individual case.
Additional damages may include lost wages, reduced earning capacity, pain and suffering, permanent impairment, long-term infection complications, and wrongful-death damages where permitted by applicable law.
Compensation amounts vary by case. Past results do not guarantee future outcomes.
Legal Process Overview
Free case review: The initial review may address the endoscopic procedure, date, medical complication, device information, treatment, and available records.
Investigation. Attorneys may review medical records, device-tracking data, endoscope information, maintenance records, reprocessing records, FDA materials, and expert evidence.
Filing. A lawsuit may be filed when available evidence and governing law support one or more claims. Filing deadlines vary by jurisdiction.
Discovery/negotiation: The parties may exchange design records, device history, reprocessing documents, adverse-event information, medical evidence, microbiology results, and expert testimony while discussing potential resolution.
Resolution: A case may conclude through settlement, dismissal, court ruling, or trial. No outcome or timeline can be guaranteed.
Frequently Asked Questions About Endoscopic Procedures
Do I Have an Endoscopic Procedures Lawsuit?
A potential case may warrant review if you underwent a qualifying endoscopic procedure and subsequently suffered a serious injury meeting current screening criteria. Eligibility depends on procedure and device identification, causation, medical evidence, damages, and applicable law.
What Evidence May Support an Endoscopic Procedures Lawsuit?
Useful evidence may include procedure reports, device-tracking records, cultures, imaging, hospitalization records, operative records, transfusion documentation, reprocessing logs, and recovered device components.
Which Procedures Are Currently Included?
Current Schmidt & Clark screening includes laparoscopy, colonoscopy, ERCP, bronchoscopy, upper endoscopy, ureteroscopy, hysteroscopy, sinus endoscopy, and cystoscopy performed from 2018 to the present.
Can an Endoscope Cause a Perforation?
Perforation is a recognized potential complication of endoscopy and can occur for different reasons. A product-related claim may warrant investigation when the injury involves device breakage, detachment, malfunction, or another suspected equipment problem.
Can a Reusable Endoscope Transmit Infection?
Potentially. FDA has documented infection-transmission concerns involving reusable duodenoscopes and has investigated contamination even where facilities reported following reprocessing instructions.
What Infections Are Currently Being Screened?
Current criteria include sepsis, bacteremia, certain hospitalized bacterial infections, pneumonia or severe pulmonary infection, tuberculosis, HIV, and drug-resistant infections when the applicable timing requirements are met.
What If Part of the Scope Broke Inside Me?
Broken or detached components may require urgent retrieval or another surgical procedure. Medical records, incident reports, imaging, device records, and the recovered component can be important evidence.
How Can I Identify the Scope Used During My Procedure?
Request complete procedure records and ask the facility for device-tracking information. Those records may identify the manufacturer, model, serial number, accessories, and reprocessing history.
References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220844
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218481
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=216332
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=205324
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=185744
- https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes