HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"
Received Dec 13, 2023 · Event occurred Nov 17, 2023
Report 9610773-2023-03614 · MDR key 18320675
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
D1 FULL DEVICE NAME: HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°", SMALL LOOP, 24 FR., 12°-30°, FOR TCRIS THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT THE ELECTRODE FELL INTO THE PATIENT'S BODY DURING A GYNECOLOGICAL TRANSCERVICAL RESECTOSCOPE (TCR) PROCEDURE. NO HEALTH HAZARD REPORTED. ADDITIONAL INFORMATION FOR PATIENT'S CURRENT CONDITION, PROCEDURAL DETAILS AND OUTCOME OF THE PROCEDURE WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.
Additional Manufacturer Narrative
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE REPORTED EVENT OCCURRED DUE TO USAGE-RELATED WEAR AND TEAR WHICH HAS CONTRIBUTED TO A BREAKAGE. THE LOOP WIRE AT THE DISTAL END OF THE HIGH FREQUENCY -RESECTION ELECTRODE WEARS OUT DURING USE AND COULD BREAK, BURN OR MELT. HOWEVER, THE SUBJECT DEVICE WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.