REPROCESSED HARMONIC SCALPEL
Received Mar 14, 2017 · Event occurred Oct 28, 2016
Report 3032391-2017-00008 · MDR key 6404856
Device
Generic name
Ultrasonic Scalpel, Reprocessed
Manufacturer
Medline RenewalModel number
HAR36MLot number
307189
Product problems
- Material Fragmentation
- Device Displays Incorrect Message
- Material Fragmentation
- Device Displays Incorrect Message
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 RETURNED FOR EVALUATION. WE CONFIRMED IT HAD BEEN REPROCESSED. THE REPORTED ISSUE WAS CONFIRMED. ADDITIONALLY, WE FOUND THAT THE BLACK TISSUE PAD LOCATED AT THE TIP OF DEVICE HAD ALSO DETACHED DURING USE. WE CONFIRMED THAT ALL INSPECTION PROCESSES WERE PERFORMED ACCORDING TO SPECIFICATION. THE USER FACILITY DID NOT NOTIFY OUR FIRM AT THE TIME OF THE INCIDENT, THEREFORE FEW DETAILS SURROUNDING THE INCIDENT ARE KNOWN AT THIS TIME. THE USER FACILITY CONFIRMED THAT THE FAILURE OCCURRED DURING USE, HOWEVER, NO MEDICAL INTERVENTION, NO KNOWN PATIENT CONSEQUENCES, AND NO PROCEDURAL DELAY OCCURRED AS A RESULT. THEREFORE, WE ARE FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION. IF ADDITIONAL INFORMATION REGARDING THE INCIDENT BECOMES AVAILABLE, WE WILL UPDATE THIS REPORT.
Description of Event or Problem
A USER REPORTED THAT SHORTLY AFTER BEGINNING USE OF A REPROCESSED HARMONIC SCALPEL, THE GENERATOR BEEPED AND DISPLAYED AN ERROR MESSAGE TO "RELAX PRESSURE". THE DEVICE COULD NOT BE USED TO COMPLETE THE PROCEDURE.