BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1933742 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05267
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 PROPERLY ATTACHED TO THE HANDLE AND PROPERLY CINCHED BY THE USER. APPROXIMATELY 45 CENTIMETERS OF THE SUTURE WAS STILL ATTACHED TO THE TRIP WIRE LOOP. THE DISTAL END OF THE SUTURE WAS NOT FRAYED AS WOULD HAVE OCCURRED IF THE SUTURE FAILED IN TENSION; INSTEAD THE END APPEARED TO BE CUT EVENLY. THE LIGATOR HEAD AND BANDS WERE NOT RETURNED. A FUNCTIONAL CHECK OF THE HANDLE ASSEMBLY WAS PERFORMED AND THE HANDLE WAS ABLE TO BE TURNED WITH AN AUDIBLE CLICK BEING HEARD WITH EACH TURN. THE ROOT CAUSE IS UNDETERMINABLE DUE TO THE FACT THE LIGATOR HEAD WAS NOT RETURNED FOR EVALUATION. THE SUTURE DID NOT APPEAR TO BE FRAYED; IT IS POSSIBLE THAT THE THREAD WAS CUT PRIOR TO DEVICE RETURN. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGE TO THE SUTURE IS CONSIDERED OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED DURING AN ENDOSCOPIC VARICEAL LIGATION PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND HOWEVER; THREE BANDS DEPLOYED AT THE SAME TIME. THE CASE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED DURING AN ENDOSCOPIC VARICEAL LIGATION PERFORMED ON (B)(4), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND HOWEVER; THREE BANDS DEPLOYED AT THE SAME TIME. THE CASE WAS COMPLETED WITH ANOTHER 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 GOOD.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1