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
Product summary
- 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
out of specification