BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHE CURVED SPATULA TIP

    MDR report key: 616357 · Received July 29, 2004

    Report

    Report Number
    1717344-2004-00070
    Event Type
    Malfunction
    Date Received
    July 29, 2004
    Date of Event
    July 6, 2004
    Report Date
    July 7, 2004
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE TIP OF THE CAUTERY DEVICE DISENGAGED FROM THE HANDPIECE AND FELL INTO THE SURGICAL CAVITY. THE FACILITY REPORTS NO EVENTS HAPPENING WITH THE DEVICE THAT WOULD CAUSE THE TIP TO DISENGAGE. THE ELECTRODE TIP WAS CLOSED INTO THE PT. THE TIP WAS CONFIRMED BY X-RAY TO BE IN THE LOWER RIGHT PELVIC AREA. AT THIS TIME, THE PT HAS ELECTED TO NOT RETURN TO SURGERY FOR REMOVAL OF THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LHE CURVED SPATULA TIP ELECTRO-SURGICAL ELECTRODE TIP GEI VALLEYLAB * 09/30/2008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other