BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3120144 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-04163
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE FOUND THAT ALL BANDS HAD BEEN FIRED FROM THE LIGATOR HEAD. THERE WAS NO DAMAGE TO THE LIGATOR HEAD TEETH. THE THREAD HAD PULLED FREE FROM THE LIGATOR, AFTER THE BANDS HAD BEEN DEPLOYED. THE TRIP WIRE WAS PROPERLY CINCHED IN THE HANDLE SLOT, AND THE TRIP WAS WOUND AROUND THE HANDLE SPOOL. THE DEVICE WAS IN A NORMAL CONDITION FOR A DEVICE THAT HAD CORRECTLY DEPLOYED ALL SEVEN BANDS; NO DEFECTS, OR DAMAGE, WERE FOUND. THEREFORE, REPORTED DEFECT WAS NOT ABLE TO BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A PROCEDURE ON SOMETIME IN (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FIVE BANDS WERE ABLE TO BE DEPLOYED PROPERLY. THE OTHER TWO BANDS MISFIRED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE DETAILS OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING A PROCEDURE ON SOMETIME IN (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FIVE BANDS WERE ABLE TO BE DEPLOYED PROPERLY. THE OTHER TWO BANDS MISFIRED. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE DETAILS OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222456 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 15586411

    Patients

    Seq Age Sex Outcome Treatment
    1