ETHICON

Additional Manufacturer Narrative

IT WAS INITIALLY REPORTED THAT THE TEFLON PADS ON TWO REPROCESSED ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY (36CM) FELL OFF DURING USE. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE INITIAL REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL/EVENT DETAILS. IT IS UNKNOWN IF THE TEFLON PADS FELL INTO SURGICAL SITE AND WHAT MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE PIECE THAT FELL OFF FROM THE DEVICE, IF IT FELL INTO THE SURGICAL SITE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. A SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE TEFLON PADS OF TWO REPROCESSED ETHICON HARMONIC ACE®+ SHEARS FELL OFF DURING USE.