REPROCESSED ABLATION ELECTRODE
Received Feb 23, 2017 · Event occurred Jan 13, 2017
Report 3032391-2017-00004 · MDR key 6354018
Device
Generic name
Electrosurgical Accessory
Manufacturer
Medline RenewalModel number
AC 4045-01Lot number
324004
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 RETURNED FOR EVALUATION, AND WE CONFIRMED THAT THE DEVICE HAD BEEN REPROCESSED. THE REPORTED ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT ALL VALIDATED PARAMETERS WERE MET AND ALL REQUIRED INSPECTIONS WERE PERFORMED. THIS IS THE FIRST REPORT OF THIS TYPE OF FAILURE FOR THIS DEVICE; THEREFORE, WE WILL CONTINUE TO MONITOR TRENDS. UNFORTUNATELY, WE DO NOT HAVE ENOUGH INFORMATION AT THIS TIME TO DETERMINE THE ROOT CAUSE OF THE FAILURE. HOWEVER, IF ADDITIONAL INFORMATION SURROUNDING THE INCIDENT IS RECEIVED THEN THIS REPORT WILL BE UPDATED. THE USER REPORTED A 20-30 MINUTE DELAY DURING THE PROCEDURE BUT THERE WAS NO PATIENT CONSEQUENCE OR SUBSEQUENT INJURY. THEREFORE IN AN ABUNDANCE OF CAUTION, WE ARE 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. THE TIP WAS DETECTED VIA X-RAY AND WAS REMOVED AT THE TIME OF THE PROCEDURE.