FDA-Device2024-05-08Class II
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
Olympus Corporation of the Americas
Hazard
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to the device resulting in delay in surgery.
Sold states
Worldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.
Affected count
850 units: (400 units US);(450 units OUS)
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0537CJDA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1700-2024Don't want to check this manually?
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