MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS
Received Apr 13, 2026 · Event occurred Mar 19, 2026
Report 3007960282-2026-00068 · MDR key 24866379
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22702SLot number
1000221803
Product problems
- Break
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 LOOP BROKE AT THE END OF THE ELECTRODE. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.