HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°
Received Mar 10, 2026
Report 3007960282-2026-00044 · MDR key 24561111
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47506SLot number
NI
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 HAD THE LOOP CUT DURING A THERAPEUTIC TCR PROCEDURE. 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
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 RECEIVED FROM CUSTOMER.