BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION STANDARD SNARE OVAL

    MDR report key: 1133739 · Received August 20, 2008

    Report

    Report Number
    3005099803-2008-03119
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE AN ELECTRICAL FAILURE OCCURRED. THE TARGET POLYP WAS IN AN UNSPECIFIED COLONIC LOCATION. A SENSATION STANDARD OVAL SNARE HAD BEEN ADVANCED TO TREAT THE TARGET POLYP. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE DEVICE WAS PLUGGED INTO THE UNSPECIFIED TYPE GENERATOR AND "NO ELECTRICAL CURRENTS WERE PASSED". THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATION STANDARD SNARE OVAL FDI BOSTON SCIENTIFIC M00562673 11382207

    Patients

    Seq Age Sex Outcome Treatment
    1