|
Catalog Number 530.610 |
Device Problem
Battery Problem (2885)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
It was reported from (b)(6) that the battery device did not run.It was further reported that the motor on the device was defective.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays in the surgical procedure and a spare device was not available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.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 coupling tool side was defective and the saw drive shaft was broken.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|