BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AURIGA

    MDR report key: 6099496 · Received November 14, 2016

    Report

    Report Number
    6099496
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 6, 2016
    Manufacturer
    STARMEDTEC GMBH
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING A LASER LITHOTRIPSY CASE THE LASER MACHINE REPEATEDLY REVERTED TO STANDBY WITH "ENERGY PEAK TO LOW" MESSAGE. ALL SETTINGS WERE CHECKED/CONFIRMED BY OPERATING ROOM TEAM AND SURGEON AND APPEARED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749892 AURIGA POWERED LASER SURGICAL INSTRUMENT GEX STARMEDTEC GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1