MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
Received May 20, 2026 · Event occurred Apr 14, 2026
Report 3007960282-2026-00110 · MDR key 25236517
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22702SLot number
1000221804
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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 THE RESECTION ELECTRODE WAS BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.