Recalls / —
—#170901
Product
Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- FDA product code
- NWB — Endoscope, Accessories, Narrow Band Spectrum
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K143153
- Affected lot / code info
- Serial Number 2506043 and 2619818
Why it was recalled
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Recalling firm
- Firm
- Olympus Corporation of the Americas
- Address
- 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610
Distribution
- Distribution pattern
- US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Timeline
- Recall initiated
- 2018-12-17
- Terminated
- 2020-11-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.