MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Received Apr 28, 2026 · Event occurred Mar 2, 2026
Report 3007960282-2026-00090 · MDR key 25020975
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22302DLot number
1000200183
Product problems
- Material Deformation
Patient
73 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE RESECTION ELECTRODE HAD EXCESSIVE BENDING AT THE DISTAL TIP. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE AND COMPLETED USING A SIMILAR 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.