BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PUSH METHOD

    MDR report key: 1140643 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04169
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE EVENT IS UNDETERMINED. THE JULY 2008 15-MONTH INITIAL G-TUBE ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    AN ENDOVIVE SAFETY PEG KITS PUSH METHOD DEVICE WAS USED DURING A PEG PLACEMENT PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCALPEL STUCK IN THE LOCKED POSITION (SHEATHED); IT "WOULD NOT OPEN." REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KITS PUSH METHOD DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KITS PUSH METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566481 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK