Recall Z-0644-2024 ยท HET Laparoscope, Gynecologic (And Accessories)
Olympus Corporation of the Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
| Date | Jan 5, 2024 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| Reason | Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes |
| Root cause | Labeling Change Control |
| Action | Olympus Medical Systems Corporation issued Urgent Medical Device Correction Letter on November 20, 2023. Letter states reason for recall, health risk and action to take: Olympus requires you to take the following actions: During an evaluation of user implementation of the Instructions for Use related to the reprocessing of the LTF-S190-5 videoscope, Olympus observed deviations from the following reprocessing steps detailed in the respective Reprocessing Manual Instructions. These steps are required for the proper reprocessing of these videoscopes. Therefore, Olympus is reminding users that f |
| Quantity | 1403 units US |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 Olympus Medical Systems Corp., Sep 17, 2021 |