Catalog Number 4206000000 |
Device Problem
Unintended Ejection (1234)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 07/04/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during testing prior to a surgical procedure at the user facility, the device would not retain a blade.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
|
|
Manufacturer Narrative
|
The reported blade retention issue was confirmed by a manufacturer repair technician through functional evaluation.Upon disassembly, corrosion was found throughout the motor and drivetrain, and it was found that the chuck and yoke assembly were bent, which can lead to the reported event.
|
|
Event Description
|
It was reported that during testing prior to a surgical procedure at the user facility, the device would not retain a blade.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
|
|
Manufacturer Narrative
|
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
|
|
Search Alerts/Recalls
|