Device product
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.
Z-1815-2022
Product summary
- Event
- Event 90788
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44 units (5/box); 133 units (5/box) OUS
- Official record key
device-enforcement:Z-1815-2022
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: 00821925044579 Lot Numbers: CA191182 CA191183 CA191184 CA191185 CA191186 CA236235 CA236237 FR230559
Distribution pattern: Nationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREA
Derived failure modes
-
Potency or specification failure
out of specification