HF-RESECTION ELECTRODE
Received Nov 13, 2023 · Event occurred Sep 20, 2023
Report 9610773-2023-03267 · MDR key 18125745
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D1: HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", LOOP, 24 FR., STANDARD, 12°-30°, FOR TCRIS. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS PROVIDED.
Description of Event or Problem
OLYMPUS RECEIVED MEDWATCH MW5146204 BY EMAIL ON OCTOBER 17, 2023. THE MEDWATCH STATES THAT DURING A CYSTOSCOPY PROCEDURE, THE PLASMA LOOP BROKE DURING USE. THE LOOP WAS RETRIEVED WITHOUT COMPLICATIONS, NO RETAINED OBJECTS. THERE WERE NO REPORTS OF HARM. THERE WERE NO REPORTS OF DELAY.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IT IS MOST LIKELY THAT THE REPORTED ISSUE WAS DUE TO WEAR AND TEAR. ADDITIONALLY NOTED THAT THE LOOP AT THE DISTAL END OF THE ELECTRODE WEARS OUT DURING USE AND MAY BREAK, BURN, OR MELT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.