HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", BUTTON, OVAL, 24 FR., 12°-30°
Received Jun 3, 2026 · Event occurred Dec 10, 2024
Report 3007960282-2026-00117 · MDR key 25375545
Device
Generic name
Hf-resection Electrode "plasma-ovalbutton"
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22766SProduct problems
- Excessive Heating
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION: THE MOST PROBABLE CAUSE OF THE COMPLAINT WAS NO PROBLEM DETECTED, EITHER IT WAS NOT CONFIRMED THAT THERE WAS A PROBLEM WITH THE DEVICE, OR IT WAS CONFIRMED THAT THERE WAS NO PROBLEM WITH THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTION ELECTRODE EXHIBITED ELECTRODE SEVERELY BENT PROXIMAL END AND THE DISTAL END LOOP WAS BENT. THERE WAS NO PATIENT INVOLVEMENT.