ETHICON

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TEFLON PAD ON THE DISTAL JAW OF THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS, W/O ADAPTIVE TISSUE TECHNOLOGY 36CM, FELL OFF INTO PATIENT'S SURGICAL SITE. THE PROCEDURE BEING DONE IS UNKNOWN. NO INFORMATION WAS PROVIDED ON HOW THE TEFLON PAD WAS RETRIEVED FROM THE PATIENT'S SURGICAL SITE. MEDICAL INTERVENTION WAS REPORTEDLY REQUIRED AND THE PATIENT NEEDED ADDITIONAL ANESTHESIA AS A RESULT OF THE INCIDENT. THERE WAS NO REPORTED SERIOUS INJURY RELATED TO THIS EVENT. DUE TO THE REPORTED EVENT AND MEDICAL INTERVENTION REQUIRED, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE COMPLAINT WAS CONFIRMED. A POTENTIAL ROOT CAUSE OF THE DEVICE FAILURE IS OVER-USE BY THE END USER. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND THIS INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED AT THE TIME THE LOT WAS PROCESSED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TEFLON PAD ON THE DISTAL JAW OF THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS FELL OFF INTO PATIENT/SURGICAL SITE.