BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3899363 · Received June 4, 2014

    Report

    Report Number
    3004378299-2014-00039
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 9, 2014
    Report Date
    June 3, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO A DEFECTIVE DIODE. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "NO FIBER DETECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327893 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. IG-1470

    Patients

    Seq Age Sex Outcome Treatment
    1