BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR II

    MDR report key: 1070478 · Received July 7, 2008

    Report

    Report Number
    3005099803-2008-01063
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A POLYP TREATMENT PROCEDURE, THE HANDLE FAILED TO FUNCTION. A CAPTIVATOR II POLYPECTOMY SNARE HAD BEEN ADVANCED TO TREAT AN UNSPECIFIED COLON POLYP. THE PHYSICIAN WAS UNABLE TO COMPLETE THE PROCEDURE WITH THIS DEVICE AS THE HANDLE WAS UNABLE TO FUNCTION PROPERLY. 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 CAPTIVATOR II FDI BOSTON SCIENTIFIC M00561291 11382204

    Patients

    Seq Age Sex Outcome Treatment
    1