Olympus Corporation of the Americas: EVIS EXERA III Duodenovideoscope Recalled for Risk of Patient Infection

Agency Publication Date: August 28, 2023

Summary

Olympus is recalling approximately 6,426 EVIS EXERA III DUODENOVIDEOSCOPE (Model TJF-Q190V) devices following reports of patient infections. These medical scopes are used for specialized gastrointestinal procedures, and the recall was initiated due to concerns regarding potential contamination and infection risks to patients. If you or a family member have recently undergone a procedure involving this specific duodenoscope model, you should monitor for signs of infection and discuss any concerns with your healthcare provider.

Risk

The device has been linked to patient infections, which can occur if the scope is not properly cleaned and disinfected between uses or if the device design allows for the buildup of biological material. This poses a moderate to high risk of cross-contamination and the spread of healthcare-associated infections between patients.

What You Should Do

Identify if your facility is using the EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V with UDI-DI 04953170405563. This recall affects all serial numbers for this specific model.
Immediately contact your healthcare provider or the Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229 to receive instructions regarding the updated reprocessing or return procedures outlined in their notification letter.
Healthcare providers should review their cleaning and sterilization protocols for the TJF-Q190V to ensure they are following the most recent manufacturer instructions to mitigate infection risks.
If you are a patient who has recently undergone a procedure with this device and are experiencing fever, abdominal pain, or other signs of infection, contact your doctor immediately.
For additional questions or to report any adverse events, contact the FDA's medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and updated instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V

Model / REF:

TJF-Q190V

UDI-DI: 04953170405563

Lot Numbers:

All Serial No.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92703

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Authorized medical distributors; Direct sales to hospitals and clinics

Manufactured In: United States

Units Affected: 6,426 units

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify if your facility is using the EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V with UDI-DI 04953170405563. This recall affects all serial numbers for this specific model.

Immediately contact your healthcare provider or the Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229 to receive instructions regarding the updated reprocessing or return procedures outlined in their notification letter.

Healthcare providers should review their cleaning and sterilization protocols for the TJF-Q190V to ensure they are following the most recent manufacturer instructions to mitigate infection risks.

If you are a patient who has recently undergone a procedure with this device and are experiencing fever, abdominal pain, or other signs of infection, contact your doctor immediately.

For additional questions or to report any adverse events, contact the FDA's medical device hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.