Device product
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
Z-1885-2020
Product summary
- Event
- Event 85204
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1238 boxes. 3 units per box.
- Official record key
device-enforcement:Z-1885-2020
Official wording
Reason: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Code information: NTI Catalog Number 72-00198-0.
Distribution pattern: US Nationwide distribution. No governmental.
Derived failure modes
-
Unknown
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.