BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE FUSION UNIPOLOR BOVIE CORD W/UNIVERSAL PL

    MDR report key: 3618986 · Received October 30, 2013

    Report

    Report Number
    1530493-2013-00003
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    August 27, 2013
    Report Date
    October 30, 2013
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PRODUCT WAS USED DURING A LAPAROSCOPIC PROCEDURE. THE CORD WAS PLUGGED INTO THE INSTRUMENT. WHEN THE DOCTOR TURNED THE POWER ON, THE CORD SEPARATED JUST ABOVE THE PLUG. THE PROCRDURE WAS COMPLECTED BY SUBSTITUTING ANOTHER CORD ON THE INSTRUMENT. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557872 CARE FUSION UNIPOLOR BOVIE CORD W/UNIVERSAL PL UNIPOLAR BOVIE CORD WITH UNIVERSAL PLUG GEI OLSEN MEDICAL LLC 88-9199 025919

    Patients

    Seq Age Sex Outcome Treatment
    1