BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF-RESECTION ELECTRODE

    MDR report key: 16059345 · Received December 28, 2022

    Report

    Report Number
    9610773-2022-00767
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    December 5, 2022
    Report Date
    January 26, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051689
    PMA / PMN Number
    K100275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT NO INFORMATION WAS OBTAINED. THE DHR REVIEW SHOWED THERE IS NO NON-CONFORMITY ASSOCIATED WITH THIS DEVICE WITH RESPECT TO THE DESCRIBED ISSUE AND THE DEVICE WAS MANUFACTURED ACCORDING TO VALID INSTRUCTIONS AND MET ALL SPECIFICATIONS. THE MOST PROBABLE CAUSE OF THE REPORTED ISSUE IS MOST LIKELY DUE TO WEAR AND TEAR. IT SHOULD BE MENTIONED THAT THE LOOP AT THE DISTAL END OF THE ELECTRODE WEARS OUT DURING USE AND MAY BREAK, BURN OR MELT. IN GENERAL, THE CUSTOMER IS REQUIRED TO CHECK THE FUNCTION OF ALL DEVICES USED PRIOR TO A PROCEDURE. ADDITIONALLY, ACCORDING TO THE IFU, A SUITABLE REPLACEMENT DEVICE MUST BE PROVIDED DURING AN APPLICATION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    PMA/510K: ADDITIONAL 510K NUMBER: K120418. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED TO OLYMPUS THAT DURING USE OF THE HF- RESECTION ELECTRODE, LOOP, 24 FR., 0,2 WIRE THE DEVICE BROKE INSIDE OF THE PATIENT. THE PHYSICIAN MANAGED TO REMOVED IT FROM THE PATIENT, AND ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. ADDITIONALLY, THE PROCEDURE WAS DELAYED BY 30 MINUTES. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432980 HF-RESECTION ELECTRODE HF-RESECTION ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22306D 1000088470 14042761051689

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention