BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URETEROSCOPIC STONE BASKET

    MDR report key: 1881881 · Received October 8, 2010

    Report

    Report Number
    1018233-2010-00107
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 8, 2010
    Report Date
    September 9, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BASKET WAS VISUALLY EXAMINED. WHILE INSPECTING THE ACTUATING PORTION OF THE HANDLE, THE LOWER STAINLESS STEEL DRIVE WIRE WAS FOUND TO BE BENT BACK 180 DEGREES. THE SHEATH WAS FOUND TO BE PULLED APART JUST BEYOND THE STRAIN RELIEF. THE BASKET TIP AND TWO LEGS OF THE NITINOL BASKET WERE MISSING. THE RETURNED SAMPLE EXHIBITED SIGNS OF POST-MANUFACTURING DAMAGE. DUE TO THE FACT THAT ONLY ONE DRIVE WIRE WAS BENT AT 180 DEGREES, THE BASKET MOST LIKELY SAW EXCESSIVE FORCE WHILE ARTICULATED ALL THE WAY IN ONE DIRECTION. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS SECTION THE FOLLOWING: "DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENT. DO NOT ALLOW THE DEVICE TO BE DIRECTLY FIRED UPON BY ANY LITHOTRIPSY DEVICE. TO DO SO MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY." IT STATES IN THE CAUTION SECTION: "IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE." THIS PRODUCT IS MANUFACTURED AND INSPECTED BY AN OUTSIDE SUPPLIER. THE DEVICE HISTORY RECORD HAS BEEN REQUESTED, BUT NOT YET RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BASKET BROKE AT THE MOMENT OF THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEROSCOPIC STONE BASKET FFL C.R. BARD, INC. NA 03LTK030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK