Model Number ONB11STF |
Device Problems
Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/29/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Healthcare professional.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during laparoscopic cholecystectomy, on inserting the clip applier, the inner seal came loose and pushed into patient cavity.The inner seal was removed with graspers to complete the case.There was no patient injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection depicts the circular seal disengaged during a surgical procedure.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|