HF-RESECTION ELECTRODE "PLASMA-OVALBUTTON", OVAL BUTTON, 24 FR., 12°-30°
Received Feb 24, 2026 · Event occurred Feb 10, 2026
Report 3007960282-2026-00035 · MDR key 24437891
Device
Generic name
Hf-resection Electrode "plasma-ovalbutton"
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA22566SProduct problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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: VISUAL INSPECTION CONFIRMED THAT THE DISTAL END OF THE PRODUCT WAS BROKEN. THE REPORTED EVENT IS 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.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
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 RESECTION ELECTRODE BLUE AND YELLOW COATING PROTRUDED AND THE DISTAL END FELL OFF. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION IN SALINE - VAPORIZATION, THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR HARM.