V. MUELLER

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS. THE DEVICE IS BEING RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A PART OF THEIR MAYO DISSECT SCISSORS BROKE OFF. THE PATIENT RECEIVED AN X-RAY AND CONFIRMED NO INSTRUMENT PIECES WERE PRESENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION. DAMAGE (NICKS) ON THE CUTTING EDGE OF THE SCISSOR BLADES WERE OBSERVED; HOWEVER, AN EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR THE SUBJECT LOT WAS REVIEWED AND CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS CONDUCTED FOR THIS LOT OF PRODUCTS AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.