BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3122434 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-04217
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED ON VARICES IN THE ESOPHAGUS. ACCORDING TO THE COMPLAINANT, THE BANDS OF THE DEVICE WOULD NOT DEPLOY, WHEN THE HANDLE WAS TURNED. THERE WAS NO DIFFICULTY EXPERIENCED, WHILE SETTING UP THE DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A BAND LIGATION PROCEDURE PERFORMED ON VARICES IN THE ESOPHAGUS. ACCORDING TO THE COMPLAINANT, THE BANDS OF THE DEVICE WOULD NOT DEPLOY, WHEN THE HANDLE WAS TURNED. THERE WAS NO DIFFICULTY EXPERIENCED, WHILE SETTING UP THE DEVICE. NO DAMAGE WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223618 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 15709503

    Patients

    Seq Age Sex Outcome Treatment
    1