MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°/16°, ESG TURIS
Received Jun 15, 2026 · Event occurred Jun 2, 2026
Report 3007960282-2026-00123 · MDR key 25512110
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22703SProduct problems
- Flare or Flash
- Activation Failure
- Excessive Heating
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE RESECTION ELECTRODE, THE LOOP WAS CHARRED AND BURNT WHILE IN USE AND STOPPED WORKING DURING A PROCEDURE. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION (TUR), THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR 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.