MalfunctionFAS
HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TURIS
Received Mar 2, 2026 · Event occurred Feb 18, 2026
Report 3007960282-2026-00037 · MDR key 24491735
Device
Generic name
Wa22706s
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22706SLot number
1000219429
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. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.