BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET

    MDR report key: 1170527 · Received September 11, 2008

    Report

    Report Number
    1820334-2008-00506
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 18, 2008
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY, NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION OF THIS REPORT. THEREFORE, WE ARE UNABLE TO DETERMINE THE VALIDITY OF THIS REPORT. WE WILL, HOWEVER, CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    ONCE THE PRODUCT WAS INSERTED INTO THE PT LAPAROSCOPICALLY, THE STENT DID NOT DEPLOY. THE SHEATH COVERING THE STENT WAS NOT ABLE TO BE RETRACTED BACK ENOUGH FOR THE STENT TO DEPLOY. NO OTHER ALTERNATE PRODUCT WAS USED. THE PT WILL NOW HAVE TO HAVE A F/U ERCP AS SOON AS POSSIBLE TO AVOID COMPLICATIONS SUCH AS JAUNDICE AND PANCREATITIS, DUE TO THE COMMON BILE DUCT NOT DRAINING PROPERLY. NOT HAVING THE STENT IS SITU MAY MAKE DOING AN ERCP MORE DIFFICULT, AS THE STENT WOULD HAVE ACTED AS AN INDICATOR OF THE CORRECT LOCATION IN THE COMMON BILE DUCT JUNCTION INTO THE DUODENUM. THIS MAY CAUSE A LONGER SURGICAL TIME AND FURTHER PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FANELLI LAPAROSCOPIC ENDOBILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK, INC. NA 2065858

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK