BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEMKIN BIPOLAR FORCEPS W/STOPS STR. 14CM, TIP 0.7MM DIA.

    MDR report key: 22103343 · Received May 29, 2025

    Report

    Report Number
    2434839-2025-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 29, 2025
    Manufacturer
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
    Product Code
    GEI
    UDI-DI
    00841645100546
    PMA / PMN Number
    K811820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIPOLAR FORCEPS WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH EFFORT (GFE) ATTEMPTS WERE MADE REQUESTING THE DEVICE'S RETURN AS WELL AS ADDITIONAL INFORMATION REGARDING USE OF DEVICE. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. IT HAS BEEN DETERMINED THAT THE MOST RECENT PURCHASES OF THIS DEVICE BY THE REPORTING HEALTHCARE FACILITY OCCURRED IN APRIL AND JUNE OF 2018. THEREFORE, THE DEVICE WAS MANUFACTURED OVER SEVEN YEARS AGO. NO COMPLAINTS FOR BIPOLAR FORCEPS 121040BP ARE ON RECORD. IT IS NOT KNOWN WHAT ACCESSORY CORD OR GENERATOR SETTING WERE USED WITH THE FORCEPS DURING THE PROCEDURE. IT HAS NOT BEEN POSSIBLE TO CONFIRM THIS ALLEGED MALFUNCTION DUE TO INSUFFICIENT INFORMATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    ACCORDING TO THE HEALTHCARE FACILITY, A SECOND-DEGREE BURN TO CHIN WAS NOTED DURING A RHYTIDECTOMY WHILE USING THE BIPOLAR FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540110 SEMKIN BIPOLAR FORCEPS W/STOPS STR. 14CM, TIP 0.7MM DIA. BIPOLAR FORCEPS GEI ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. 00841645100546

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female