BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SKYLITE TIPLESS NITINOL STONE BASKET

    MDR report key: 19613950 · Received June 26, 2024

    Report

    Report Number
    19613950
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    November 30, 2023
    Report Date
    February 16, 2024
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MIDDLE-AGED MALE WAS HAVING A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, BILATERAL URETEROSCOPY, AND BILATERAL STONE BASKETING AS AN IN-PATIENT. THE UROLOGIST WAS USING THE URETERAL STONE BASKET RETRIEVAL INSTRUMENT TO REMOVE A STONE FROM THE LEFT URETER. THE INSTRUMENT BROKE INSIDE THE URETER. THE UROLOGIST THEN USED A NON-DISPOSABLE ALLIGATOR FORCEPS TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT¿S BODY. THE REFERENCE NUMBER FOR THE STONE BASKET IS 041900 AND LOT NUMBER IS NGHU0879. UNFORTUNATELY, THE DISPOSABLE PRODUCT WAS THROWN AWAY AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595939 BARD SKYLITE TIPLESS NITINOL STONE BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL C.R. BARD, INC. 041900 NGHU0879

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male