BEUDAMED
    FDA Adverse Event Other Summary report: N

    COOK-COPE TYPE LOOP BILIARY CATHETER

    MDR report key: 276166 · Received May 4, 2000

    Report

    Report Number
    1820334-2000-00041
    Event Type
    Other
    Date Received
    May 4, 2000
    Date of Event
    March 15, 2000
    Report Date
    April 7, 2000
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH POSSIBLE BILIARY TUBE DISPLACEMENT. WHEN ATTEMPTING TO CHANGE BILIARY TUBE, THE CATHETER WAS WITHDRAWN WITH GREAT RESISTANCE. IT APPEARS A SMALL SEGMENT OF THE STRING HAD FRAGMENTED AND PROBABLY REMAINS IN THE BILE DUCT. NO FURTHER HARM TO PT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK-COPE TYPE LOOP BILIARY CATHETER SPECIAL SET FGE COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other