BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

    MDR report key: 20138771 · Received September 4, 2024

    Report

    Report Number
    9610773-2024-02119
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    February 23, 2023
    Report Date
    August 29, 2025
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PMA/510(K) NUMBER: K100275/K120418.THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. CORRECTION: D9 ADDITIONAL INFORMATION: D8, H3, H4, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ELECTRODE WAS USED SEVERAL TIMES BY THE USER. THE REPORTED EVENT WAS LIKELY DUE TO RESERIALIZATION OF A SINGLE USE DEVICE AND WEAR/TEAR (THE LOOP AT THE DISTAL END OF THE ELECTRODE WEARS OUT DURING USE AND CAN BREAK, BURN OR MELT). OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE RESECTION ELECTRODE HAD THE DISTAL END BURNT. THE ISSUE OCCURRED DURING PREPARATION FOR THE THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699281 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12° HF-RESECTION ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22302D 1000089607 14042761051665

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown