Device product
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 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.
Z-0645-2024
Product summary
- Event
- Event 93575
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 271 units US
- Official record key
device-enforcement:Z-0645-2024
Official wording
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
Code information: UDI-DI: 04953170310386 All Serial Numbers
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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