HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°
Received Mar 4, 2026
Report 3007960282-2026-00038 · MDR key 24512707
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47506SLot number
NI
Product problems
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DATE OF EVENT IS UNKNOWN, ADDITIONAL INFORMATION WILL BE PROVIDED ONCE AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A TRANSVAGINAL ENDOSCOPIC MYOMECTOMY FOR UTERINE FIBROIDS, THE ELECTRODE WAS BENT WHEN IT WAS PRESSED DURING DETACHING THE FIBROID. THE TIP OF ELECTRODE FELL OFF INTO THE UTERUS. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE FALLEN OFF PIECE AND REPLACING WITH SAME DEVICE. THERE WAS NO HEALTH HAZARD REPORTED.