Catalog Number 511100150060 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/10/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that the ring of a 1.5mm coupler fell out of the "u port"; anastomosis could not be completed.This issue was identified during patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
H10: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|