—#181356

Product

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

FDA product code: EOB — Nasopharyngoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K181240
Affected lot / code info: Serial Numbers 2901130 2901567 2901655 2901548 7900416 7900638 7900546 7900590 2901700 2901410 2901456 2901451 2901414 2901435 2901428 2901437 2901624 2901753 2901788 2801008 2801059 2801069 2801072 2801046 2801023 2901343 2801076 2801010 2801009 2801019 2901891 7900545 2801059 TEST1 TEST2 2801072 7900644 2901529 2801051 7900360 7900187 7900362 7900542 7900589 2801008 7900264 2801058 2801007 2801012 7900612

Why it was recalled

Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On May 5, 2020, the firm distributed Urgent Medical Device Corrective Action letters to affected customers. Customers were informed that their endoscopes were incorrectly repaired and may be missing an O-ring in the battery holder. Customers were asked to take the following actions: 1. Immediately cease use of the affected endoscope. Olympus will repair your unit free of charge and provide a replacement loaner until repairs can be completed. 2. An Olympus representative will contact you to make arrangements for return of your affected endoscope. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0171 and provide your contact information as indicated in the portal. If you require additional information, please contact the firm at (484) 896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.

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 including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.

Timeline

Recall initiated: 2020-05-05
Terminated: 2020-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.