BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7¿

    MDR report key: 2961897 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00882
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2013-00881 AND 3005099803-2013-00882 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 LIGATOR DEVICES WERE TO BE USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE WITHIN THE ESOPHAGUS PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER ADVANCING THE FIRST SPEEDBAND DEVICE (MFR # 3005099803-2013-00881) INTO THE PATIENT, THE LIGATOR HEAD WAS NOTED AS BEING "RIGID" WITH A "ROUGH" TEXTURE. REPORTEDLY, THIS LED TO AN ESOPHAGEAL ABRASION, HOWEVER, NO BLEED OCCURRED. THE SCOPE WAS WITHDRAWN FROM THE PATIENT, THE DEVICE WAS EXCHANGED, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER SPEEDBAND SUPERVIEW SUPER 7 LIGATOR DEVICE. FOLLOW-UP WAS RECEIVED ON (B)(4) 2013, WHICH REVEALED THAT AFTER THE FIRST SPEEDBAND DEVICE WAS WITHDRAWN FROM THE PATIENT, A SECOND SPEEDBAND DEVICE (MFR # 3005099803-2013-00882) WAS OPENED; HOWEVER, THE LIGATOR HEAD WAS NOTED AS BEING "ROUGH" SO THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A THIRD SPEEDBAND SUPERVIEW SUPER 7 LIGATOR DEVICE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS BEING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66097 SPEEDBAND SUPERVIEW SUPER 7¿ LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253

    Patients

    Seq Age Sex Outcome Treatment
    1