BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 3021542 · Received March 26, 2013

    Report

    Report Number
    3005099803-2013-02110
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEICE REVEALED THAT THE 2 IRRIGATION TUBES HAD NO ISSUES. THE LIGATOR HEAD WAS RETURNED WITH THE SHRINK WRAP REMOVED. THE WHITE SUTURE THREAD JOINING THE ADAPTOR RING TO THE HOUSING HAD BEEN PULLED AWAY FROM THE ADAPTOR RING, AND THE ADAPTOR RING HAD BEEN PARTIALLY DETACHED FROM THE HOUSING. SIX BANDS REMAINED ON THE LIGATOR HEAD WITH THE DISTAL BAND ROLLED OUT OF POSITION. THE SEVENTH BAND HAD BEEN DEPLOYED AND WAS NOT RETURNED. THE SUTURE WAS BROKEN, MOST LIKELY DURING REMOVAL OF THE DEVICE FROM THE SCOPE TIP. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS HANDLING DAMAGE. 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

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED AS BEING OVER 18 YEARS OLD. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTICED THAT THE BANDS ON THE LIGATOR HEAD WERE MOVED OUT OF POSITION AND TWISTED. THERE WAS NO DAMAGE TO THE PACKAGING NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, IT WAS NOTICED THAT THE BANDS ON THE LIGATOR HEAD WERE MOVED OUT OF POSITION AND TWISTED. THERE WAS NO DAMAGE TO THE PACKAGING NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7 DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123262 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 15593203

    Patients

    Seq Age Sex Outcome Treatment
    1