UNKNOWN
Received Mar 21, 2016 · Event occurred Mar 3, 2016
Report 2520274-2016-11748 · MDR key 5513627
Device
Product problems
- Sticking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BURR DEVICE WOULD NOT FULLY LOCK INTO THE HANDPIECE DEVICE; THEN IT BECAME STUCK AND WOULD NOT UNLOCK. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE AS AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO 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.