BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3910181 · Received July 2, 2014

    Report

    Report Number
    3005099803-2014-02406
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS OF SUTURE BROKEN. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THE SUTURE LOOP WAS BROKEN WITH A PORTION STILL ATTACHED TO THE TRIP WIRE LOOP. ALL SEVEN BANDS WERE PRESENT ON THE LIGATOR HEAD WITH THE FIRST BLUE BAND MOVED SLIGHTLY. THERE WAS NO DAMAGE NOTED TO THE LIGATOR HEAD TEETH. THE ADAPTOR RING WAS SECURELY ATTACHED TO THE HEAD AND NO HOLES WERE NOTED IN THE RING. THE TRIP WIRE CRIMP WAS CAUGHT BEHIND THE HANDLE SLOT WHICH PREVENTED TIGHTENING OF THE WIRE DURING DEVICE SET-UP. FUNCTIONAL EVALUATION WAS PERFORMED BY TURNING THE HANDLE AT 180 DEGREES AND AN AUDIBLE CLICK WAS HEARD, NO ISSUE WAS NOTED WITH THE HANDLE ASSEMBLY. THE TRIP WIRE WAS NOT PROPERLY SECURED DURING DEVICE SET-UP AS OUTLINED IN THE DFU, SHOWN BY THE TRIP WIRE CRIMP BEING CAUGHT IN THE HANDLE ASSEMBLY SLOT. BASED ON THE EVALUATION OF THE RETURNED DEVICE, USER / USE ERROR IS SELECTED AS THE MOST PROBABLE ROOT CAUSE CLASSIFICATION A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    NOTE: THIS IS ONE OF THREE REPORTS RELATED TO THE SAME EVENT (MFR. REPORT #3005099803-2014-02405, MFR. REPORT #3005099803-2014-02406 AND MFR. REPORT #3005099803-2014-02407). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE SPEEDBAND SUPERVIEW SUPER 7 DEVICES WERE USED DURING A LIGATION PROCEDURE IN THE ESOPHAGUS PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DRAW THE USE THE FIRST SPEEDBAND DEVICE (THE SUBJECT OF MFR. REPORT #3005099803-2014-02405); HOWEVER THE LESION COULD NOT BE DRAWN INTO THE LIGATOR HOUSING. THE SAME ISSUE OCCURRED WITH THE SECOND SPEEDBAND DEVICE(THE SUBJECT OF MFR. REPORT #3005099803-2014-02406) AND THIRD SPEEDBAND DEVICE(THE SUBJECT OF MFR. REPORT #3005099803-2014-02407). A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SUTURE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387016 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542251 16529249

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR