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Recall Observatory FDA recall evidence

Device product

Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.

Z-1813-2022

August 12, 2022

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 90788
Status
Ongoing
Classification
Class II
Quantity
27 units (5/box) US; 83 units(5/box) OUS
Official record key
device-enforcement:Z-1813-2022

Official wording

Reason: 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

Code information: UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

Distribution pattern: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification