MalfunctionFAS
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received Apr 24, 2026 · Event occurred Mar 27, 2026
Report 3007960282-2026-00088 · MDR key 24990509
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DLot number
NI
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 WIRE WAS NOT IN SHAPE. THE ISSUE WAS FOUND DURING A THERAPEUTIC RESECTION WITH PLASMA PROCEDURE AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.