HARMONIC ACE+7 SHEARS W/ ADV. HEMOSTASIS

Additional Manufacturer Narrative

IT WAS REPORTED FROM THE CUSTOMER THAT THE PRODUCT DID NOT WORK. BOX ON BOOM READ 'REPLACE INSTRUMENT.' WE TRIED TO RESET HANDPIECE IN CORD BEFORE REPLACING." THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

Description of Event or Problem

IT WAS REPORTED FROM THE CUSTOMER, THE PRODUCT DID NOT WORK. BOX ON BOOM READ 'REPLACE INSTRUMENT. WE TRIED TO RESET HANDPIECE IN CORD BEFORE REPLACING.