BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINE NEEDLE ELECTRODE

    MDR report key: 2051984 · Received April 8, 2011

    Report

    Report Number
    2051984
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 8, 2011
    Manufacturer
    COVIDIEN VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    NEEDLE TIP BOVIE BROKE DURING HYPOSPADIAS REPAIR. ROOM STAFF SEARCHED FOR MISSING PIECE WITHOUT SUCCESS. X-RAY TAKEN IN ROOM AFTER SURGERY ENDED AND DRESSING WAS PLACED. NEEDLE TIP BOVIE PIECE WAS FOUND UNDER THE SURGICAL BED AFTER X-RAY WAS TAKEN BUT NOT YET READ. DOCTOR NOTIFIED THAT UPON FINDING THE BOVIE PIECE THAT THE COUNT WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINE NEEDLE ELECTRODE NEEDLE ELECTRODE GEI COVIDIEN VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO