—#193859

Product

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

FDA product code: FDS — Gastroscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545

Why it was recalled

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take: 1. Identify the affected model and serial number in the subject of this letter. 2. An Olympus representative will contact you to arrange for the return of your affected device. Olympus will repair your unit free of charge. 3. Olympus will provide for a service loaner in an effort to not disrupt patient care. Please do not hesitate to contact @ 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the states of AL, FL, NC, NY.

Timeline

Recall initiated: 2022-04-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193859. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.