BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1203294 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05377
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN INFORMED BOSTON SCIENTIFIC THAT THE SPEEDBAND SUPERVIEW SUPER 7 LIGATOR WAS PROPERLY SET-UP ON THE SCOPE. THE VARICES WERE SUCTIONED AND WHEN THE PHYSICIAN TRIED TO DEPLOY THE BANDS, THERE WAS NO CLICK. THE PHYSICIAN NOTICED THAT THE BAND WAS NOT ON THE AFFECTED AREA. A SECOND ATTEMPT WAS TRIED ON A DIFFERENT VARICES AND THE SAME THING HAPPENED. THE DEVICE WAS CHANGED FOR A NEW ONE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. THERE WAS NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR MND BOSTON SCIENTIFIC CORPORATION M00542251 11932458

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK