BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILSON COOK MEDICAL

    MDR report key: 170865 · Received June 3, 1998

    Report

    Report Number
    MW1013904
    Event Type
    Injury
    Date Received
    June 3, 1998
    Date of Event
    January 22, 1998
    Report Date
    June 3, 1998
    Manufacturer
    WILSON COOK MEDICAL, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH SPHINCTEROTOMY. AFTER CAPTURING A STONE WITH THE STONE BASKET, AN ATTEMPT WAS MADE TO REMOVE THE STONE. THE WIRES WHICH OPERATE THE BASKET BROKE AT THIS TIME NEAR THE DEVICE'S HANDLE. THE WIRES WERE TAPED TO THE PT'S FACE. THE NEXT MORNING (01-23-98) THE PT WENT TO SURGERY FOR REMOVAL OF THE STONE, BASKET, AND WIRES. THE HOSP DID NOT FEEL THIS SITUATION WAS AN ADVERSE EVENT SINCE IT WAS DETERMINED THE STONE WAS TO BIG TO BE REMOVED USING THE ENDOSCOPE. THEREFORE, THE PT WOULD HAVE REQUIRED SURGERY FOR STONE REMOVAL ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON COOK MEDICAL STONE RETRIEVAL BASKET FFL WILSON COOK MEDICAL, INC. MSB-21-2X4 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization