ULTRASONIC SCALPELS
Received Jun 14, 2017 · Event occurred May 22, 2017
Report 3032391-2017-00016 · MDR key 6640780
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE IN QUESTION WAS NOT RETURNED FOR EVALUATION. IT CANNOT BE CONFIRMED THAT THE DEVICE WAS REPROCESSED. HOWEVER, THE LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THE REPORTED ISSUE WAS COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED. THE USER FACILITY CONFIRMED THAT THE PAD WAS RETRIEVED FROM THE PATIENT AT THE TIME OF THE PROCEDURE; GENERAL ANESTHESIA WAS USED; HOWEVER THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT WE DO NOT HAVE ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE AT THIS TIME, HOWEVER IF MORE INFORMATION IS PROVIDED THEN THIS REPORT WILL BE UPDATED. HOWEVER, IN AN ABUNDANCE OF CAUTION, WE ARE FILING THIS MEDWATCH REPORT.
Description of Event or Problem
WE RECEIVED A REPORT INDICATING WHILE USING A REPROCESSED HARMONIC SCALPEL, THE BLACK TISSUE PAD LOCATED ON THE DISTAL TIP, DETACHED DURING USE.