Catalog Number BLACKMAX-N |
Device Problems
Air Leak (1008); Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/06/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
This is report 2 of 2 of the same event.It was reported that during a discectomy surgical procedure, it was observed that the craniotome device broke into two and the motor device sounded like it had an air leak.According to the report, the two devices were being used together when the event occurred.There was an unspecified delay to the surgical procedure.It was unknown if there were spare devices available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|