ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING A LAP SLEEVE, THE REPROCESSED ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM WOULD NOT SEAL A VESSEL. PER REPORT, THE PATIENT HAD TO BE ADMINISTERED MORE ANESTHESIA MEDICATION AND THE PROCEDURE WENT OVER THE EXPECTED TIME. GENERAL ANESTHESIA WAS USED AND THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. THERE WAS NO SERIOUS INJURY REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED. UPON TESTING ON SAMPLE TISSUE, THE DEVICE FUNCTIONED AS EXPECTED. A REVIEW OF THE REPROCESSING RECORD WAS PERFORMED AND INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. 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 DURING A LAP SLEEVE, THE REPROCESSED HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM WOULD NOT SEAL A VESSEL. PROCEDURE WENT OVER THE EXPECTED TIME AND PATIENT HAD TO BE ADMINISTERED MORE ANESTHESIA MEDICATION.