BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR

    MDR report key: 1328387 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01436
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    October 21, 2005
    Report Date
    October 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    0/25/2005 INITIAL MDR WAS: "BLANK" SHOULD HAVE BEEN: 2005.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS A SUPPLEMENT TO MANUFACTURER REPORT #3005099803-2008-1436.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED TO PERFORM A VARICEAL LIGATION. ACCORDING TO THE COMPLAINANT, THE BANDS WERE COMING OFF PREMATURELY . THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION-SPENCER M00542251

    Patients

    Seq Age Sex Outcome Treatment
    1