Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
|
Patient Problem
Abrasion (1689)
|
Event Date 01/29/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is available for return.A follow up report will be filed once the quality investigation is complete.
|
|
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.It was further reported that the event caused a short delay.It was further reported that the procedure was completed successfully.
|
|
Manufacturer Narrative
|
The perforator product reported involved with this event was not returned for evaluation.Without the perforator involved with this event the reported failure of failure to disengage could not be confirmed.Device not available for return.
|
|
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 it was further reported that the event caused a short delay.It was further reported that the procedure was completed successfully.
|
|
Manufacturer Narrative
|
The perforator product reported involved with this event was returned for evaluation.The disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.
|
|
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.It was further reported that the event caused a short delay.It was further reported that the procedure was completed successfully.
|
|
Search Alerts/Recalls
|