MalfunctionFAS
HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
Received May 20, 2026 · Event occurred May 7, 2026
Report 3007960282-2026-00109 · MDR key 25236135
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22351CLot number
1000197046
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE DISTAL END OF THE RESECTION ELECTRODE CAME OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC CYSTECTOMY OF THE URETHRA AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.