BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    MDR report key: 1203224 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05359
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOVIVE SAFETY PEG KIT DEVICE WAS USED DURING A PEG PLACEMENT PROCEDURE THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE "THE SCALPEL WAS IN THE LOCKED POSITION. IF THEY COULD GET IT OPENED, IT WOULD STAY OPEN. A BASIC SCALPEL WAS USED TO COMPLETE THE PROCEDURE." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566461 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK