MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TCRIS
Received May 12, 2026 · Event occurred Feb 25, 2026
Report 3007960282-2026-00100 · MDR key 25153172
Device
Generic name
Endoscopic Electrosurgical Electrode, Bipolar, Single-use
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47707SProduct 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 BIPOLAR LOOP BROKE. THE ISSUE WAS FOUND DURING A BIPOLAR TRANSURETHRAL RESECTION OF THE PROSTATE, THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.