Model Number 8886848813 |
Device Problems
Mechanical Problem (1384); Failure to Fire (2610)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during a laparoscopic cholecystectomy procedure, the clips of the device were not able to disengage from the cartridge and the clips were not able to form correctly.A new device was used to complete the case.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual examination of the cartridge noted that the clip was fully formed but not completely deployed from the cartridge.Since the clinical instrument was not received the loading unit was loaded into a pmv representative instrument and fired; the pusher advanced properly and deployed the clip.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the clip not fully deployed condition may occur if the trigger of the instrument is not fully actuated releasing the clip from the cartridge.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|