Device product
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.
Z-1814-2022
Product summary
- Event
- Event 90788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 231.4 units (5/box); 510 units (5/box) OUS
- Official record key
device-enforcement:Z-1814-2022
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: 00821925044555 Lot Numbers: CA191233 CA191234 CA191235 CA233514 CA233515 CA233516 CA233517 CA233518 CA236206 CA236208 CA236213 CA236215 CA236216 CA236217 CA236220 CA236227 CA236228 CA236230 CA236238 CA236240 CA236243 CA236261 CA236272 CA236273 CA236276 CA236278 CA236290
Distribution pattern: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Derived failure modes
-
Potency or specification failure
out of specification