BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-TEMP

    MDR report key: 1630239 · Received March 9, 2010

    Report

    Report Number
    1630239
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 9, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING CASE (BILATERAL INFERIOR OBLIQUE MYECTOMY AND BILATERAL MEDIAL RECTUS RECESSION), THE MEDTRONIC ACCUTEMP CAUTERY 844200, LOT NUMBER: 60524400 WAS FAULTY. ACCUTEMP CAUTERY WAS REMOVED FROM FIELD AND REPLACED WITH A NEW ACCUTEMP CAUTERY WHICH FUNCTIONED PROPERLY. PATIENT WAS NOT ADVERSELY AFFECTED BY THIS. PER OPERATING ROOM SUPERVISOR, THE DEVICE WAS NOT HEATING UP ENOUGH TO PROVIDE CAUTERIZATION TO THE SURGICAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-TEMP CAUTERY DEVICE GEI MEDTRONIC * 605244400

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO