Device product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Z-1889-2019
Product summary
- Event
- Event 82973
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1059 boxes
- Official record key
device-enforcement:Z-1889-2019
Official wording
Reason: Observed reported incidence rate for harm associated with intraoperative bleeding
Code information: All lot numbers
Distribution pattern: Nationwide Foreign: CANADA, AUSTRALIA, BELGIUM
Derived failure modes
-
Unknown
Observed reported incidence rate for harm associated with intraoperative bleeding