FDA-Device2022-10-05Class II
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Olympus Corporation of the Americas
Hazard
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
Sold states
Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Affected count
44 units (5/box); 133 units (5/box) OUS
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1815-2022Don't want to check this manually?
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