HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, FOR TCRIS
Received Mar 6, 2026 · Event occurred Feb 15, 2026
Report 3007960282-2026-00041 · MDR key 24536100
Device
Generic name
Wa47551s
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47551SLot number
NI
Product problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. 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 PROVIDED BY THE CUSTOMER.
Additional Manufacturer Narrative
E1: (B)(6). 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 LOOP WAS BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC HYSTEROSCOPIC FASCIECTOMY AND COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.