BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2903529 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00104
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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 DEVICE WAS USED FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITHIN THE ESOPHAGUS, PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO BAND A GRADE 4 VARIX, TWO OF THE BANDS DETACHED FROM THE VARIX AFTER DEPLOYMENT AND WERE LEFT IN THE PATIENT TO PASS NATURALLY. THE CASE WAS COMPLETED WITH THIS SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. 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
    12655 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 0015573163

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR