BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2973044 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00760
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT AND PROCEDURE DATE OF (B)(6) 2013 WAS REPORTED ON THE INITIAL MDR. HOWEVER, THE COMPLAINT LISTED THE EVENT DATE AS (B)(6) 2013 AND THE PROCEDURE DATE AS (B)(6) 2013. FOLLOW-UP WAS RECEIVED ON (B)(6) 2013, WHICH CONFIRMED THAT BOTH THE EVENT AND PROCEDURE OCCURRED ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00760 AND MANUFACTURER REPORT # 3005099803-2013-00761 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED FOR AN UPPER GASTROINTESTINAL PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN DEPLOYMENT WAS ATTEMPTED, THE SPEEDBAND DEVICE (MFR # 3005099803-2013-00761) WOULD NOT DEPLOY. REPORTEDLY, THE BANDS STARTED TO DEPLOY HOWEVER; WOULD NOT RELEASE OFF THE LIGATOR HEAD. A SECOND SPEEDBAND DEVICE (MFR # 3005099803-2013-00760) WAS THEN USED, HOWEVER; WHEN AN ATTEMPT TO DEPLOY A BAND WAS MADE, THREE BANDS FIRED AT THE SAME TIME. THE CASE WAS COMPLETED WITH A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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 FINE.

    Description of Event or Problem · 1

    CORRECTION: THE PROCEDURE WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75913 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 0015248853

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR