BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

    MDR report key: 2060178 · Received April 15, 2011

    Report

    Report Number
    3005099803-2011-01241
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    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

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. 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 THAT THE HANDLE HAD RESIDUE ON IT INDICATIVE OF BEING USED. THE TRIP WAS CINCHED UPON RECEIPT OF THE DEVICE AND THERE ARE SIGNS OF DEFORMATION IN THE SLOT WHERE THE WIRE WAS CINCHED. IT APPEARED AS AN ATTEMPT WAS MADE TO WIND THE TRIP WIRE ON THE HANDLE SPOOL AS THERE WERE DEFORMITIES IN VARIOUS LOCATIONS ALONG THE LENGTH OF THE WIRE. THE DISTAL END OF THE TRIP WIRE WAS CUT WHICH IS COMMON PRACTICE TO BE ABLE TO REMOVE THE DEVICE FROM THE SCOPE. IN ADDITION, THE SUTURE WAS NOT ATTACHED. THE SYRINGE LINE APPEARED TO HAVE TAPE RESIDUE ON IT. THE LIGATOR HEAD WAS RECEIVED IN THE ORIGINAL POUCH, WHICH HAD NOT BEEN OPENED. ALL BANDS AND SUTURE WERE PRESENT ON THE LIGATOR HEAD. NO DAMAGE WAS OBSERVED ON THE LIGATOR HEAD OR THE POUCH WHICH IT WAS RETURNED IN. FUNCTIONALLY, THE TRIP WIRE WAS FREED FROM THE HANDLE AND WAS ABLE TO BE RE-CINCHED. THE HANDLE WAS ABLE TO BE ROTATED HEARING THE ¿CLICK¿ APPROXIMATELY EVERY 180 DEGREE OF ROTATION. THE COMPLAINT CAN NOT BE CONFIRMED AS EVIDENT OF THE LIGATOR HEAD NOT BEING OPENED AND USED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. 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 SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING A HEMORRHOID BANDING PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND MORE THAN ONE BAND DEPLOYED AT THE SAME TIME. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING A HEMORRHOID BANDING PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND MORE THAN ONE BAND DEPLOYED AT THE SAME TIME. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF 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
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 13835006

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR