HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 30°
Received Apr 21, 2026 · Event occurred Mar 25, 2026
Report 3007960282-2026-00082 · MDR key 24947468
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22306DLot number
1000208226
Product problems
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE RESECTION ELECTRODE APPEARED BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
E1: (B)(6) HOSPITAL. 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: THE MOST PROBABLE CAUSE FOR THE MALFUNCTION WAS TRACED TO COMPONENT FAILURE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.