Catalog Number 0810000000 |
Device Problem
Smoking (1585)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/05/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
|
|
Event Description
|
It was reported that during equipment testing conducted at the user facility the device was smoking.No patient involvement, no delay to a surgical procedure, no medical intervention, and no adverse consequences were reported with this event.
|
|
Manufacturer Narrative
|
Upon disassembly, it was observed that the motor wire was rubbing against the coils on the drive.The device was scrapped.
|
|
Event Description
|
It was reported that during equipment testing conducted at the user facility the device was smoking.No patient involvement, no delay to a surgical procedure, no medical intervention, and no adverse consequences were reported with this event.
|
|
Search Alerts/Recalls
|