PK FRONT LOAD,IGLESIAS,WORKING ELEMENT
Received Aug 20, 2019 · Event occurred Jul 23, 2019
Report 2951238-2019-01059 · MDR key 8910940
Device
Generic name
Pk Front Load,iglesias,working Element
Manufacturer
Gyrus Acmi, IncModel number
EIWE-PKFLLot number
UNKNOWN
Product problems
- Crack
- Crack
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE WORKING ELEMENT WILL NOT BE RETURNED TO THE SERVICE CENTER FOR EVALUATION AS IT WAS DISCARDED DURING THE PROCEDURE. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THE INSTRUCTION MANUAL WARNS USERS ¿TO ENSURE SATISFACTORY PERFORMANCE, PERFORM THE PRESCRIBED INSPECTIONS AS RECOMMENDED. EXAMINE THIS DEVICE PRIOR TO USE. DO NOT USE IF DAMAGE IS FOUND.¿
Description of Event or Problem
THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) PROCEDURE, THE WORKING ELEMENT WAS CRACKED CAUSING THE ELECTRODE TO SHORT OUT. THERE WAS NO REPORT OF SPARKING OR SMOKE. THE GENERATOR SETTINGS WERE 160/80. THE CRACKED WORKING ELEMENT WAS DISCARDED AND A REPLACEMENT WAS USED WITH THE SAME ELECTRODE AND GENERATOR TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED BY JUST A FEW MINUTES. THERE WAS NO UNEXPECTED BLEEDING. THERE WAS NO PATIENT INJURY REPORTED.