MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Received Jun 29, 2026 · Event occurred May 23, 2026
Report 3007960282-2026-00129 · MDR key 25658784
Device
Generic name
Electrode, Electrosurgical, Active, Urological
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22302DLot number
1000187856
Product problems
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE RESECTION ELECTRODE ELECTRIC CUTTING LOOP WAS FRACTURED. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL PLASMA RESECTION OF THE PROSTATE AND WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.