BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2830256 · Received November 13, 2012

    Report

    Report Number
    3005099803-2012-05283
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED FOR A BAND LIGATION PROCEDURE, WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WAS TURNED IN AN ATTEMPT TO DEPLOY A BAND HOWEVER; THE BAND FAILED TO DEPLOY. THE HANDLE WAS TURN AGAIN HOWEVER; TWO BANDS DEPLOYED AT THE SAME TIME. THE CASE WAS COMPLETED WITH THIS DEVICE. PRIOR TO USE, NO DAMAGE WAS VISIBLE TO THE DEVICE OR ITS PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 15192741

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR