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Recall Observatory FDA recall evidence

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

November 06, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
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

    reason.no_named_rule · v1.0.0

    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.