BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 2073543 · Received May 2, 2011

    Report

    Report Number
    3005099803-2011-01493
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THERE WAS RESIDUE PRESENT ON THE ENTIRE DEVICE INDICATING USE. ALL THE BANDS FROM THE LIGATOR HEAD WERE MISSING AND ONE OR TWO TEETH ON THE LIGATOR APPEAR TO BE SLIGHTLY DAMAGE. THE TRIP WIRE WAS DISTORTED AS IF THERE WAS AN ATTEMPT TO WIND THE TRIP WIRE ONTO THE SPOOL OF THE HANDLE. A PORTION OF THE TRIP WIRE WAS ALSO WOUND AROUND THE DRUM, INDICATING THE HANDLE HAD BEEN TURNED TO DEPLOY THE BANDS. SLIGHT INDENTATIONS EXIST IN THE GROOVE OF THE SPOOL INDICATING THAT AN ATTEMPT HAD BEEN MADE TO CINCH THE WIRE DURING USE. THE SUTURE WAS ATTACHED TO THE DISTAL END OF TRIP WIRE. THE LENGTH OF THE VELCRO BELT WAS FOUND TO BE WITHIN SPECIFICATION. A FUNCTIONAL CHECK OF THE HANDLE FOUND THAT THE HANDLE KNOB WAS ABLE TO TURN TO TAKE UP SLACKS AND THERE WAS AN AUDIBLE "CLICK" HEARD AT EACH COMPLETE TURN. THE REPORTED EVENT OF FAILED TO DEPLOY AND MISFIRE WERE NOT ABLE TO BE CONFIRMED SINCE ALL BANDS ON THE LIGATOR HEAD WERE NOT PRESENT. IN ADDITION, THE REPORTED EVENT THAT THE VELCRO STRAP COULD NOT BE TIED TO THE ENDOSCOPE TIGHTLY ENOUGH, COULD NOT BE CONFIRMED AS THE VELCRO BELT WAS MEASURED AND WAS FOUND TO BE WITHIN THE PRODUCT SPECIFICATION. HOWEVER, THE FAILURE LIKELY OCCURRED DUE TO OPERATIONAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE AS EVIDENT OF THE SLIGHT DAMAGE TO THE LIGATOR TEETH. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION IS NOT AVAILABLE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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.

    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 ESOPHAGEAL VARICE LIGATION PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ATTEMPTED WAS MADE TO DEPLOY A BAND HOWEVER, THE BAND DID NOT DEPLOY. ANOTHER ATTEMPT TO DEPLOY A BAND WAS MADE AND TWO BANDS DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT THE DEVICE WAS NOT PROPERLY ATTACHED , IT WAS NOT TIGHT ENOUGH ON THE ENDOSCOPE. 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 STABLE.

    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 ESOPHAGEAL VARICE LIGATION PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ATTEMPTED WAS MADE TO DEPLOY A BAND HOWEVER, THE BAND DID NOT DEPLOY. ANOTHER ATTEMPT TO DEPLOY A BAND WAS MADE AND TWO BANDS DEPLOYED AT THE SAME TIME. IT WAS REPORTED THAT THE DEVICE WAS NOT PROPERLY ATTACHED , IT WAS NOT TIGHT ENOUGH ON THE ENDOSCOPE. 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 STABLE.

    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 72 YR