Catalog Number 261221 |
Device Problem
Fail-Safe Did Not Operate (4046)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Manufacturer Narrative
|
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
A facility reported a codman perforator that plunged.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
The perforator was returned for evaluation.Device history record (dhr) review - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Unit was heavily soiled with organic matter and had rust forming between the inner/outer drill.Ifu and functional testing performed and passed the test.The returned unit was found to work as intended and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Additional information received: the manufacturer of the drill used with the perforator was medtronic (pneumatic).The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.
|
|
Search Alerts/Recalls
|