Model Number 176645 |
Device Problem
Failure to Align (2522)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/16/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, prior to laparoscopic cholecystectomy procedure, misalignment of the jaws was noted.The same events occurred in a row.There was no patient injury.
|
|
Manufacturer Narrative
|
Additional:evaluation summary: post market vigilance (pmv) led an evaluation of one device.Engineering verified that jaw alignment of device was within specifications.Engineering inspected jaws under a microscope and found no physical damage to the jaws.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, prior to laparoscopic cholecystectomy procedure, misalignment of the jaws was noted.The same events occurred in a row.The procedure was completed with another device.There was no patient injury.
|
|
Search Alerts/Recalls
|