Device product
Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -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 the female reproductive organs.
Z-0697-2024
Product summary
- Event
- Event 93601
- Status
- Ongoing
- Classification
- Class II
- Quantity
- WA50040A : 561 units; WA50042A: 857 units
- Official record key
device-enforcement:Z-0697-2024
Official wording
Reason: Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.
Code information: UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Unknown
Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.