HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received Apr 23, 2026 · Event occurred Mar 26, 2026
Report 3007960282-2026-00085 · MDR key 24969070
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DLot number
1000187458
Product problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE HF-RESECTION ELECTRODE HAD A DISTORTED DISTAL END OF THE ELECTRODE BEFORE USE. THIS MALFUNCTION OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
E1 - INITIAL REPORTER ESTABLISHMENT NAME - (B)(6) MEDICAL CENTER. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.