Model Number EEATAID25D |
Device Problems
Break (1069); Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/20/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, the device had a recurring issue.The surgeon attempted to push the stapler through incision to reanastomoses and the introducer broke.The introducer was immediately replaced with a new one.Everything was removed from patient cavity.There was no patient injury.No medical intervention required.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The introducer is broken at the grasping notch.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failure.Replication of the observed condition may occur if excessive force is used to insert the instrument with the introducer.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|