HF-RESECTION ELECTRODE "PLASMAROLLER", ROLLER, 24 FR., 12°-30°, FOR TCRIS
Received Feb 24, 2026
Report 3007960282-2026-00034 · MDR key 24430516
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE HF-RESECTION ELECTRODE LOOP WAS BENT. THE ISSUE WAS FOUND DURING A THERAPEUTIC HYSTEROSCOPIC FASCIECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
B5: NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER. H2: ADDITIONAL INFORMATION, DEVICE EVALUATION. H3: ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION. 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.