BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP

    MDR report key: 2850035 · Received October 22, 2012

    Report

    Report Number
    2850035
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 22, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PROBE WOULD NOT WORK, VENDOR DID NOT BRING A BACK UP AND PATIENT REMAINED UNDER ANESTHESIA >6 HOURS. THERE WAS NO PATIENT HARM BEYOND EXTENDED ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN * 213535X

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR