Recall Z-0417-2024 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Aizu Olympus Co., Ltd.
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
| Date | Nov 29, 2023 (initiated Oct 16, 2023) |
| Status | Open, Classified |
| Reason | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection. |
| Root cause | Process control |
| Action | On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com. |
| Quantity | 24 incorrectly repaired units |
| Distribution | Domestic distribution to FL, KY, MA, NJ, NY, and PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131780 | EVIS EXERA III VIDEO SYSTEM Olympus Medical Systems Corp., Aug 29, 2013 |