BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 2002981 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00653
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE HANDLE ASSEMBLY, TRIP WIRE AND EXTENSION LINE WERE WITHOUT ISSUE. THE BANDS WERE INTACT ON THE LIGATOR HEAD AND WERE STILL COVERED WITH SHRINK WRAP. THE SUTURE LOOP WAS DETACHED AND NOT RETURNED. THE SUTURE PORTION ATTACHED TO THE LIGATOR HEAD WAS BROKEN AT APPROXIMATELY 2.5 CENTIMETERS FROM THE ADAPTOR RING. A SECOND PIECE OF SUTURE WAS APPROXIMATELY 9 CENTIMETERS LONG. THE SUTURE ENDS APPEAR FRAYED AND TWISTED AS IF UNDERGONE EXTREME TENSILE FORCE. THE CONDITION OF THE DEVICE RETURNED WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE SUTURE WAS BROKEN, AS EVIDENT OF THE SUTURE BEING CUT IN TWO PLACES. HOWEVER, IT IS UNKNOWN IF THE DEFECT OCCURRED DUE TO CUSTOMER HANDLING/PREP OF THE DEVICE. THEREFORE THE MOST PROBABLE 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.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING A BANDING PROCEDURE PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY WERE TAKING UP THE SLACK IN THE TRIP WIRE, THE SUTURE FROM THE LIGATION BAND SNAPPED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING A BANDING PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN THEY WERE TAKING UP THE SLACK IN THE TRIP WIRE, THE SUTURE FROM THE LIGATION BAND SNAPPED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 13921413

    Patients

    Seq Age Sex Outcome Treatment
    1