FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0645-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0645-2024
- Event ID
- 93575
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- November 20, 2023
- Classification Date
- January 5, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
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.
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 Info
UDI-DI: 04953170310386 All Serial Numbers
Distribution
Nationwide
Quantity
271 units US