UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Aug 5, 2014 · Event occurred Jul 10, 2014
Report 0001811755-2014-02794 · MDR key 3980776
Device
Product problems
- Bent
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ATTACHMENT WAS WOBBLING WHEN THE BUR WAS INSERTED INTO THE CHUCK. THE DEVICES WERE SENT TO ANOTHER DEPARTMENT FOR TESTING AND IT WAS NOTICED THAT THE 2 BURS USED WERE BENT. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR RETURN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED BY CUSTOMER.
Additional Manufacturer Narrative
THE DEVICES INVOLVED IN THIS REPORTED EVENT WERE NOT RETURNED FOR EVALUATION. THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE ASSOCIATED HANDPIECE'S IFU LIST POSSIBLE POTENTIAL CAUSES FOR THE REPORTED EVENT AS APPLICATION OF EXCESSIVE PRESSURE WITH THE CUTTING ACCESSORY, THE USE OF A DAMAGED ATTACHMENT, CUTTING ACCESSORY AND/OR HANDPIECE, THE USE OF THE WRONG SIZE CUTTING ACCESSORY, OR THE CUTTING ACCESSORY EXTENDS TOO FAR FROM THE DISTAL END OF THE ATTACHMENT OR IS NOT PROPERLY CENTERED IN THE ATTACHMENT. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT THE ATTACHMENT WAS WOBBLING WHEN THE BUR WAS INSERTED INTO THE CHUCK. THE DEVICES WERE SENT TO ANOTHER DEPARTMENT FOR TESTING AND IT WAS NOTICED THAT THE 2 BURS USED WERE BENT. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT IMPACT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.