BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 LIGATOR

    MDR report key: 1202100 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05321
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION WAS INFORMED ABOUT A GENERAL PRODUCT PROBLEM A PHYSICIAN IS EXPERIENCING WITH THE SPEEDBAND SUPERVIEW SUPER 7 LIGATOR BAND(S) FALLING OF THE VARIX. THERE IS NO INFORMATION ON SPECIFIC PATIENT(S) INVOLVED OR QUANTITY OF DEVICES; ATTEMPTS BY THE MANUFACTURER TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE PHYSICIAN REPORTED THAT THE SYSTEM IS PREPARED ACCORDING TO THE INSTRUCTIONS. SUCTION ACTIVATED AND THE BAND(S) DEPLOYED ACCORDINGLY LIGATING THE LESION, BUT SHORTLY AFTER THE BAND(S) FALL OFF THE VARIX. THE PHYSICIAN INDICATED THE BAND(S) SEEM TO HAVE LESS RETRACTION POWER THAN IN THE PAST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA