SURGICAL KNIFE HANDLE #3L LONG 8-3/8IN

Additional Manufacturer Narrative

(B)(4). UPON CAREFUSION INVESTIGATION/EVALUATION OF DEVICE, A FOLLOW UP EMDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

(B)(4): THE FOLLOWING WAS INITIALLY REPORTED TO CAREFUSION: ¿THE OPEN HEART OR STAFF IS SAYING THEY ARE HAVING A HARD TIME GETTING THE KNIFE BLADES OFF THE 3L KNIFE HANDLE WE GOT AND ONE NURSE GOT CUT TRYING TO GET IT OFF. I DON¿T THINK THAT THEY HAD ANY PROBLEM GETTING THEM ON JUST TRYING TO GET THEM OFF. I WAS NOT SURE IF WE SHOULD SEND THEM BACK IN OR WHAT YOU WANTED TO DO. I WANTED TO SEE WHAT YOU THINK." ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON MAY 6, 2015. ¿A NURSE WAS CUT TRYING TO REMOVE THE BLADE OFF KNIFE HANDLE. THE NURSE REQUIRED STITCHES. THE PROCEDURE THAT TOOK PLACE WAS AN OPEN HEART SURGERY(VALVE) ON (B)(6) 2015. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO THE PROCEDURE. THE INSTRUMENT HAS NEVER BEEN REPAIRED. THE CURRENT CONDITION OF THE NURSE IS "FINE". THE COMPLAINT SAMPLES WERE RETURNED AND AN EVALUATION WAS PERFORMED. THE INSTRUMENTS WERE MANUFACTURED IN JANUARY OF 2015. A PERFORMANCE TEST AND ANALYSIS WERE DONE WITH THE INSTRUMENTS AND NO IRREGULARITIES WERE FOUND. THE HANDLES WITH BLADES WERE INSPECTED BY THE PRODUCTION TEAM AND THEY FOUND THAT THE BLADES WERE EASY TO INSERT AND REMOVE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM WAS PERFORMED FOR THIS PRODUCT OVER THE LAST 2 YEARS. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS INSTRUMENT OF ANY KIND DURING THIS TIME PERIOD. THE REPORTED ISSUE WILL CONTINUE TO BE TRENDED AND EVALUATED BY CAREFUSION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THIS LOT NUMBER. THERE WERE NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. UNFORTUNATELY, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED FOR THE ISSUE YOU EXPERIENCED. IT IS POSSIBLE THE INCORRECT BLADE HAD BEEN USED OR THE INSTRUMENT WAS MISHANDLED.

Description of Event or Problem

CUSTOMER STATED "THE OPEN HEART OR STAFF IS SAYING THEY ARE HAVING A HARD TIME GETTING THE KNIFE BLADES OFF THE 3L KNIFE HANDLE WE GOT AND ONE NURSE GOT CUT TRYING TO GET IT OFF. I DON¿T THINK THAT THEY HAD ANY PROBLEM GETTING THEM ON JUST TRYING TO GET THEM OFF. A NURSE WAS CUT TRYING TO REMOVE THE BLADE OFF KNIFE HANDLE. THE NURSE REQUIRED STITCHES. THE PROCEDURE THAT TOOK PLACE WAS AN OPEN HEART SURGERY(VALVE) ON (B)(6) 2015. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THE INSTRUMENT WAS NOT INSPECTED PRIOR TO THE PROCEDURE. THE INSTRUMENT HAS NEVER BEEN REPAIRED. THE CURRENT CONDITION OF THE NURSE IS "FINE".