BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR 6-OV-XS

    MDR report key: 3986427 · Received July 30, 2014

    Report

    Report Number
    3986427
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 28, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    MND
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE ESOPHAGEAL BANDER WAS FIRMLY PUSHED ONTO THE END OF THE ENDOSCOPE. PLACEMENT WAS CONFIRMED BY THE GI NURSE AND THE PHYSICIAN. THE BANDER DISLODGED FROM THE END OF THE SCOPE DURING INTRODUCTION INTO THE PATIENT'S MOUTH. IT WAS REPOSITIONED AND IT CAME OFF AGAIN. A SECOND BANDER WITH THE SAME LOT # WAS LOADED AND IT ALSO CAME OFF THE END OF THE SCOPE. UNABLE TO USE THE PRODUCT ON THIS PATIENT. THE PATIENT WAS NOT HARMED. BOTH PRODUCTS WERE SAVED. OTHER DEVICES WITH THIS LOT NUMBER WERE REMOVED FROM SUPPLY AVAILABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445374 COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR 6-OV-XS LIGATOR, ESOPHAGEAL MND COOK MEDICAL MBL-6-OV-XS W3429861
    445375 COOK MEDICAL 4,6,10 SHOOTER SAEED MULTI-BAND LIGATOR 6-OV-XS LIGATOR, ESOPHAGEAL MND COOK MEDICAL MBL-6-OV-XS W3429861

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR NO OTHER THERAPIES