HF-RESECTION ELECTRODE "PLASMALOOP ¿ LARGE, 30°", LARGE LOOP, 24 FR., 12°-30°, F
Received Mar 23, 2026 · Event occurred Mar 4, 2026
Report 3007960282-2026-00053 · MDR key 24670982
Device
Generic name
Wa47507s
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47507SLot number
1000187678
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 THAT THE RESECTION ELECTRODE LOOP PORTION OF THE DISTAL END OF THE ELECTRODE HAD CAME OFF. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE AND WAS COMPLETED USING IN SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: WAS DUE TO A COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.