UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Jan 4, 2016 · Event occurred Dec 10, 2015
Report 0001811755-2016-00001 · MDR key 5339843
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
IT WAS CONFIRMED THAT THE DEVICE WAS DROPPED BY THE USER AT THE ACCOUNT CAUSING THE EVENT.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE HANDPIECE DRILL FELL AND THE BUR BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE HANDPIECE DRILL FELL AND THE BUR BROKE. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.