HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received Mar 16, 2026 · Event occurred Feb 26, 2026
Report 3007960282-2026-00047 · MDR key 24606276
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DProduct problems
- Degraded
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE DISTAL END OF THE PRODUCT BEING BENT CANNOT BE DETERMINED, BUT DEFORMATION DUE TO OVERLOAD IS A POSSIBLE EXPLANATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
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 HF-RESECTION ELECTRODE LOOP'S WIDTH OF THE DISTAL END BECAME NARROW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.