BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX

    MDR report key: 9271334 · Received November 4, 2019

    Report

    Report Number
    9271334
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 16, 2019
    Report Date
    October 30, 2019
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A UROLOGICAL PROCEDURE A FRAGMENT OF THE HOLMIUM LASER FIBER BROKE OFF INTO THE PATIENT'S LEFT KIDNEY. THE SURGEON RETRIEVED THE FRAGMENT THAT HE COULD SEE; BARD PROFLEX 273, REF # LSU273PF, LOT 14819004. LASER LITHOTRIPSY WAS PERFORMED USING A HOLMIUM LASER FIBER. THE STONE WAS OBLITERATED INTO SMALL FRAGMENTS UNDER DIRECT VISION. STONE FRAGMENTS WERE EXTRACTED WITH A WIRE BASKET AND SENT FOR STONE ANALYSIS. A SMALL FRAGMENT OF THE LASER FIBER WAS VISUALIZED IN THE CALYX AND REMOVED WITH A URETERAL BIOPSY FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068193 PROFLEX POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC LSU273PF 14819004

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA