—#170900

Product

Olympus PCF-Q180AC Video Colonoscope - 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: K100584
Affected lot / code info: Serial Number 2501374 and 2704914

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 #170900. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.