BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBER TM 200 QUANTA SYSTEM TURP LASER

    MDR report key: 16396667 · Received February 17, 2023

    Report

    Report Number
    MW5114997
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    February 15, 2023
    Report Date
    February 16, 2023
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE HEALTHTRONICS LASER HAD BEEN USED FOR APPROXIMATELY 5-10 MINUTES, THE TIP WAS RECUT AND USED FOR A FEW MORE MINUTES, SURGEON WAS JUST CLEANING UP THE PROSTATE AND ABOUT FINISHED WHEN IT STOPPED WORKING, THEN THERE WAS A LOUD CRACK AND PEOPLE NOTICED THE 2-3 INCH FLAMES COMING DIRECTLY FROM THE CONNECTION FROM THE FIBER TO THE LASER MACHINE. EMERGENCY STOP BUTTON WAS PRESSED BY THE REP AND A TOWEL USED TO SMOTHER THE SMALL FLAMES. THE REP WAS ON-SITE AND EQUIPMENT WAS REMOVED FROM SERVICE AND EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161715 CYBER TM 200 QUANTA SYSTEM TURP LASER POWERED LASER SURGICAL INSTRUMENT GEX QUANTA SYSTEM, S.P.A. PUM S00009

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention