BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2900087 · Received January 7, 2013

    Report

    Report Number
    3005099803-2013-00054
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    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

    (B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.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 # 3005099803-2013-00054 AND MANUFACTURER REPORT # 3005099803-2013-00055 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICES WERE USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER ADVANCING THE SPEEDBAND DEVICE (MR # 3005099803-2013-00054) INTO THE PATIENT, DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE BAND FAILED TO DEPLOY. REPORTEDLY, THE HANDLE WAS TURNED AGAIN AND THREE BANDS DEPLOYED TOGETHER. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND A SECOND SPEEDBAND DEVICE (MR # 3005099803-2013-00055) WAS THEN USED, BUT THE SAME ISSUE OCCURRED; THE FIRST BAND FAILED TO DEPLOY AND WHEN THE HANDLE WAS TURNED FOR A SECOND TIME, THREE BANDS RELEASED. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING A THIRD SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8035 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251

    Patients

    Seq Age Sex Outcome Treatment
    1