BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3910253 · Received July 2, 2014

    Report

    Report Number
    3005099803-2014-02416
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED ISSUE OF BANDS FAILED TO DEPLOY. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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 RETURNED DEVICE FOUND SOME RESIDUE PRESENT INDICATING USE/HANDLING. THE SUTURE WAS BROKEN WITH PORTIONS ATTACHED TO BOTH THE LIGATOR HEAD AND THE TRIP WIRE LOOP. THE LIGATOR HEAD WAS RETURNED WITH DAMAGED TEETH. ALL SEVEN BANDS WERE PRESENT ON THE LIGATOR HEAD; HOWEVER, THEY WERE MOVED OUT OF POSITION AND APPEARED TANGLED AND WERE DAMAGED. THE TRIP WIRE WAS SECURED IN THE HANDLE ASSEMBLY SLOT; HOWEVER, ITS PROXIMAL END HAD BEEN CUT OFF AND NOT RETURNED. FUNCTIONAL EVALUATION OF THE HANDLE WAS PERFORMED AND NO ISSUES WERE NOTED. BASED ON THE EVALUATION OF THE RETURNED DEVICE, THE COMPLAINT THAT THE BANDS FAILED TO DEPLOY WAS CONFIRMED. HOWEVER, THE INVESTIGATION FAILED TO DETERMINE A PROBABLE ROOT CAUSE FOR THIS COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER 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 ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPEEDBAND DEVICE FAILED TO DEPLOY ITS BANDS. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPEEDBAND DEVICE FAILED TO DEPLOY ITS BANDS. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386738 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 16922905

    Patients

    Seq Age Sex Outcome Treatment
    1