FDA-Device2022-10-05Class II
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
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
231.4 units (5/box); 510 units (5/box) OUS
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. 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-1814-2022Don't want to check this manually?
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