|
Model Number 174233 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, occurred prior to a laparoscopic cholecystectomy procedure.Upon opening the package, tried to open and c lose the device.But it would not open completely.The device was not used on a patient.The procedure was completed with another device.
|
|
Manufacturer Narrative
|
Correction post market vigilance (pmv) led an evaluation of one device.Engineering found no abnormalities during functional testing.Engineering inspected the spread distance between the jaws and found them to be acceptable.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer's quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|