REPROCESSED ABLATION WAND

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO FOR EVALUATION. WE CONFIRMED THAT THE DEVICE HAD BEEN REPROCESSED, AND THE REPORTED ISSUE WAS CONFIRMED. MEDLINE RENEWAL WAS UNABLE TO CONFIRM IF THE TIP WAS RETRIEVED FROM THE PATIENT. OUR INVESTIGATION INCLUDED BOTH AN INSPECTION OF THE RETURNED DEVICE, AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR). WE RECONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN AT THIS TIME, HOWEVER IF ADDITIONAL INFORMATION IS RECEIVED THEN THIS REPORT WILL BE UPDATED. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT. HOWEVER, IN AN ABUNDANCE OF CAUTION, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT.

Description of Event or Problem

WE RECEIVED A REPORT INDICATING THAT THE TIP OF A REPROCESSED ABLATION WAND DETACHED DURING USE. IT IS UNKNOWN IF THE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM AND NO INFORMATION IF MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE INCIDENT.