BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1970020 · Received January 25, 2011

    Report

    Report Number
    3005099803-2011-00097
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 6, 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
    OTHER

    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 TRIP WIRE WAS WRAPPED AROUND THE HANDLE SPOOL AND CINCHED PROPERLY IN THE HANDLE SLOT. THE TRIP WIRE AND SUTURE WERE STILL ATTACHED AND WITHOUT ISSUE. THE LIGATOR HEAD AND BANDS WERE NOT RETURNED. FUNCTIONALLY, THE HANDLE ASSEMBLY KNOB WAS TURNED 180º AND AN AUDIBLE CLICK WAS HEARD. THE MOST PROBABLE ROOT CAUSE OF THE BANDS UNABLE TO DEPLOY CAN NOT BE DETERMINED AS THE LIGATOR HEAD AND BANDS WERE NOT RETURNED. 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 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) BANDING PERFORMED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. 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 A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. 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 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251 13783218

    Patients

    Seq Age Sex Outcome Treatment
    1