BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY HARD WIRE BASKET (4 WIRE)

    MDR report key: 185844 · Received September 2, 1998

    Report

    Report Number
    185844
    Event Type
    Injury
    Date Received
    September 2, 1998
    Date of Event
    August 14, 1998
    Report Date
    August 20, 1998
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEMORY HARD WIRE BASKET - 4 WIRE - BY WILSON COOK MEDICAL, INC. - WAS BEING USED TO EXTRACT STONE FROM PT'S COMMON BILE DUCT. WIRE BROKE, LEAVING BASKET AND APPROX 1 INCH IN PT. WIRE BASKET CONTAINED IN COMMON BILE DUCT AND END OF WIRE VISIBLE HANGING OUT OF DUCT. DIAMETER = 5 FRENCH LENGTH: 200 CM BASKET SIZE. 4 WIRE, 1.5 CM X 3.5 CM. STERILIZATION DATE- 1/26/1996. EXPIRATION DATE 1/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMORY HARD WIRE BASKET (4 WIRE) MEMORY HARD WIRE BASKET (4 WIRE) FFL WILSON-COOK MEDICAL INC. MWB5-1.5X3.5 979062039

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention CAPTIFLEX DISPOSABLE POLYPECTOMY SNARE.