HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°
Received Jul 5, 2025 · Event occurred Jun 13, 2025
Report 3007960282-2025-00097 · MDR key 22408091
Device
Generic name
Hf-resection Electrode
Manufacturer
Olympus Medical Products Czech, Spol. S R.o.Model number
WA47506SLot number
1000133943
Product problems
- Break
- Detachment of Device or Device Component
- Break
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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. UPDATED FIELDS: H6, H11. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE HOOK ELECTRODE CAME OFF AND FELL INTO THE PATIENT¿S BODY DURING A THERAPEUTIC GYNECOLOGIC TRANSCERVICAL RESECTION IN SALINE (TCRIS) PROCEDURE. THE FALLEN PART WAS RETRIEVED, AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
E1: ESTABLISHMENT NAME: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.