MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Received Apr 20, 2026 · Event occurred Mar 13, 2026
Report 3007960282-2026-00078 · MDR key 24933725
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22302DProduct problems
- Melted
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE HF-RESECTION ELECTRODE WAS MELTED. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT 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.