HARMONIC ACE+7 SHEARS 5MM X 36CM

Additional Manufacturer Narrative

A SAMPLE WAS RETURNED BY THE REPORTING FACILITY AND SAMPLE INVESTIGATION WAS COMPLETED ON (B)(6) 2021. UPON INSPECTION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE LOWER JAW WAS DAMAGED AND BENT BACKWARDS. THE JAWS WERE RE-ALIGNED, THE DEVICE WAS ACTUATED, AND THE DEVICE JAWS WERE FOUND TO ACTUATE AS EXPECTED. TO DATE, NO ADDITIONAL INFORMATION RELATED TO THE REPORTED INCIDENT HAS BEEN RECEIVED. THE REPORTED DEVICE PROBLEM/ISSUE WAS CONFIRMED, HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative

IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE JAWS OF THE HARMONIC DEVICE WERE FOUND TO BE BROKEN WHILE IT WAS WITHIN THE PATIENT. DESPITE MULTIPLE GOOD FAITH ATTEMPTS THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THE INCIDENT. NO ADVERSE PATIENT IMPACT WAS ORIGINALLY REPORTED. A ROOT CAUSE FOR THE REPORTED INCIDENT WAS UNABLE TO BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE JAWS OF THE HARMONIC DEVICE WERE FOUND TO BE BROKEN.