Device product
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
Z-1147-2021
Product summary
- Event
- Event 87231
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1147-2021
Official wording
Reason: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.
Code information: Lot Codes: 9855JEG to 93879JEG
Distribution pattern: US Nationwide distribution in the states of FL and OH.
Derived failure modes
-
Unknown
An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.