HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received May 4, 2026 · Event occurred Mar 5, 2026
Report 3007960282-2026-00095 · MDR key 25075900
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DProduct problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED THE DISTAL END OF THE PRODUCT WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
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: THIS EVENT WAS CAUSED BY A COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.