BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1191149 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04898
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT WHILE USING THE SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, THE BANDS COULD NOT BE RELEASED BY TURNING THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THE PT IS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542251 11099978

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR