BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP

    MDR report key: 3242315 · Received July 9, 2013

    Report

    Report Number
    3242315
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE BASKET WOULD NOT CLOSE ALL THE WAY. THE DEVICE WAS FOUND TO BE FAULTY AND WAS REMOVED FROM SERVICE. IT WAS REPLACED WITH A FUNCTIONING DEVICE. THERE WAS NO PATIENT HARM. I SPOKE WITH THE CHARGE NURSE IN THE OPERATING ROOM (OR), WHO STATED THAT THIS IS A RECURRING PROBLEM AND THAT THERE IS A TRANSITIONING OCCURRING TO ANOTHER COMPANY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT PERCUTANEOUS NEPHROLITHOTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314503 ZERO TIP DISLODGER, STONE FFL BOSTON SCIENTIFIC 390-105 16024755

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR