FDA-Device2024-01-17Class II
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.
Olympus Corporation of the Americas
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
WA50040A : 561 units; WA50042A: 857 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0697-2024Don't want to check this manually?
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