Duodenoscope and Endoscope Infection Lawsuits

Since 2010, waves of patient infections and deaths from scopes have occurred. FDA warnings since 2013 about duodenoscopes and endoscopes have been issued for these devices being unable to be cleaned. As a result, there have been many serious injuries and deaths resulting in state and federal courts. Thess scopes are used down the mouth, extending as far as the duodenum. Companies making reusable scopes are Olympus, Fujifilm, and Pentax.

What Infections Are Associated with Duodenoscopes and Endoscopes?

Scopes can inherently be impossible to clean. When this happens, the scopes can have the following contaminations (often called “bio-material”) which are spread to other patients:

• MRSA (Methicillin-resistant Staphylococcus aureus)
• CRE (Carbapenem-resistant Enterobacteriaceae)
• “Superbugs”
• C. diff (Clostridium difficile)
• VRE (Vancomycin-resistant Enterococcus)
• ESBL (Extended spectrum beta-lactamases)
• Multidrug-resistant Pseudomonas aeruginosa
• Multidrug-resistant Acinetobacter and Enterobacter
• HIV and tuberculosis infections

What Are the Injuries Associated with these Infections and Diseases?

Medical reports starting in 2010 detail more than 1000 patients were infected, dozens more were exposed and several people who had been infected died. The most common injuries are:

• Infection causing hospitalization for extended periods and use of intravenous antibiotics, known as a “PICC” line
• Urinary tract infections
• Sepsis: a life-threatening infection that quickly spreads through a patient’s entire body that causes organ failure
• Viral diseases, such as HIV
• Death

What Are Lawsuits Claiming?

1. Design Defect  

• Device geometry prevents adequate cleaning
• Safer alternative: disposable components or redesigned endcaps

2. Failure to Warn 

Companies allegedly:

• Knew contamination risk for years
• Delayed or softened warnings to hospitals
• Failed to recall parts and devices promptly
• Gave incomplete cleaning and processing instructions

3. Manufacturing / Quality System Defects 

• FDA findings re: inadequate reporting + quality controls
• Contamination rates even after compliant reprocessing

4. Fraud / Misrepresentation (in some cases) 

• Allegedly overstated effectiveness of sterilization protocols

Meet Esteemed Defective Device Attorney, David B. Rheingold

David B. Rheingold is a nationally recognized trial attorney and managing partner whose practice is devoted exclusively to complex drug, medical device, product liability and over-the-counter products litigation. For more than 35 years, he has represented individuals harmed by dangerous products, playing a leading role in high-profile cases involving Paragard IUDs, Camp Lejeune groundwater contamination, defective hernia mesh, IVC filters, Johnson & Johnson talc, and Roundup cancer claims, as well as landmark mass tort settlements including DePuy and Stryker hip implants, with a particular focus on cancer causing drugs and products.

Known for his individual hands-on approach with clients, David works closely with medical and scientific experts to build strong, individualized cases, is admitted in New York and Virginia, and has been repeatedly recognized by Super Lawyers and The National Trial Lawyers for his leadership in mass tort and product liability litigation.

How do Duodenoscopes and Endoscopes Work?

The duodenoscopes and endoscopes are inserted through the mouth. Doctors have the ability to see body parts by video and do surgical procedures.

The scopes travel through the:

• Mouth
• Down the esophagus
• Through the stomach
• Into the duodenum (the first part of the small intestine)

Are Medical Malpractice Claims Included in Lawsuits?

Each case is reviewed on an individual basis. Sometimes hospitals have been added as defendants based on:

• Hospital-wide outbreaks
• Proven improper cleaning procedures
• Hospital reprocessing errors

Notable Recalls for Duodenoscopes, Endoscopes and Individual Components

OLYMPUS — Key recalls & infection-related actions

TJF-Q180V Duodenoscope 

• Recall / corrective action: 2021
• Reason: Adhesive deterioration → ineffective reprocessing → contamination risk
• Infection link: Potential transmission of bacteria between patients

TJF-Q190V Duodenoscope 

• Multiple actions:  

  • 2021: Device correction (tissue contamination issues)
  • 2023: FDA recall tied to contamination/infection concerns

• Issues:  

  • Distal cap/elevator contamination risk
  • Cleaning challenges

 TJF-Q190V / TJF-Q290V / TJF-Q170V 

• Field safety notice (2025)
• Reason: Inadequate cleaning / reprocessing concerns

Olympus MAJ-891 endoscope accessory 

• FDA early alert (2024–2025)
• Reason: Infection risk
• Reported harm:  

  • ~120 injuries
  • 1 death

TJF-Q190V / TJF-145 / TJF-150 / TJF-Q180V (multiple models) 

• FDA recall (2023)
• Category: Endoscopic system components
• Risk: Contamination/infection related to device design and accessories

 PENTAX — Key recalls & infection-related actions

  ED-3490TK Duodenoscope 

• FDA safety communications (2016–2017)
• Issues:
• Cracks/gaps in distal cap adhesive
• Allows fluid and bacteria infiltration
• Risk: Cross-patient infection

ED-3490TX Duodenoscope 

• Voluntary recall / redesign
• Reason:  

  • Poor sealing → contamination risk
  • Redesigned elevator channel to improve cleaning

 Pentax Video Duodenoscopes (multiple models) 

• FDA recall (2017)
• Reason:  

  • Residual soil under distal cap / suction cylinder

• Cause: Device design
• Action: Removal and replacement

FUJIFILM — Key recalls & infection-related actions

ED-530XT Duodenoscope 

• Recall (post-2015 outbreak period)
• Reason:  

  • Design changes required to improve reprocessing

• Issue: Contamination risk

 Fujifilm duodenoscopes (general) 

• Class II recalls (multiple years)
• Issues cited:
• Defective design affecting cleaning
• Persistent contamination risk

You Deserve Reliable Medical and Legal Assistance

Suffering from a defective scope injury is not an easy. Speak with one of our knowledgeable New York duodenoscope and endoscope injury attorneys about what you could earn from a lawsuit, and if one of our trusted medical contacts can help you with follow-up operations.