BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    MDR report key: 1203177 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05337
    Event Type
    Malfunction
    Date Received
    October 17, 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 MFR DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVAL CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNK. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT AN ENDOVIVE SAFETY PEG KIT DEVICE WAS USED DURING A PEG PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SAFETY SCALPEL WAS IN THE LOCKED POSITION. IF IT COULD BE OPENED, IT WOULD STAY OPEN. REPORTEDLY, ANOTHER BASIC SCALPEL WAS USED TO COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. PT'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 M00566721 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK