Model Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
Abrasion (1689)
|
Event Date 01/03/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
A follow up report will be filed once the quality investigation is complete.Device received but awaiting evaluation results.
|
|
Event Description
|
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional dural opening as a result of this event.No further information was provided.
|
|
Event Description
|
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional dural opening as a result of this event.No further information was provided.
|
|
Manufacturer Narrative
|
H6: the quality investigation is complete.
|
|
Search Alerts/Recalls
|