MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TCRIS
Received Mar 23, 2026 · Event occurred Mar 2, 2026
Report 3007960282-2026-00054 · MDR key 24671162
Device
Generic name
Wa47707s
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47707SLot number
1000171796
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 HAD BROKE. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.