BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2992857 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01127
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, 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 DEVICE WAS USED FOR AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE WITHIN THE ESOPHAGUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE WAS ROTATED THREE TIMES AND THREE CLICKS COULD BE HEARD HOWEVER; THE BAND FAILED TO DEPLOY. THE BANDER WAS THEN ADVANCED DOWN INTO THE PATIENT STOMACH AND ALL THREE BANDS FELL OFF. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97954 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 15776129

    Patients

    Seq Age Sex Outcome Treatment
    1