ASC 4250-01 @SUPER TURBOVAC 90, 90 DEGRE

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE TIP OF THE ABLATION ELECTRODE DETACHED DURING A SHOULDER JOINT PROCEDURE AND FELL INTO THE SURGICAL SITE. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED FROM THE SURGICAL SITE USING FORCEPS. A NEW DEVICE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER REPORTED INCIDENT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. A SAMPLE HAS BEEN RECEIVED AND INVESTIGATION IS ONGOING. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION TO RETRIEVE THE DETACHED TIP FROM THE SURGICAL SITE, 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 TIP OF THE ABLATION ELECTRODE FELL OFF DURING USE.

Additional Manufacturer Narrative

INVESTIGATION OF THE RETURNED SAMPLE FROM THE REPORTING FACILITY HAS BEEN COMPLETED. THE ELECTRODE FACEPLATE WAS NOTED TO HAVE DETACHED FROM THE TIP. BURN MARKS WERE OBSERVED ON THE TOP OF THE ELECTRODE TIP AND CERAMIC. THE DAMAGED ELECTRODE FACEPLATE APPEAR TO BE DUE TO OVER ACTIVATION BY THE END-USER. THE ROOT CAUSE FOR THE REPORTED INCIDENT WAS FOUND TO BE USE ERROR. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE ANOTHER SUPPLEMENTAL MDR WILL BE FILED.