BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 4131201 · Received September 29, 2014

    Report

    Report Number
    3004378299-2014-00080
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K131081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO AN INTERNAL COMPONENT FAILURE. AFTER THE REPLACEMENT OF THIS COMPONENT, THE LASER SYSTEM RESTARTED TO WORK. WE ARE UNAWARE ABOUT PATIENT INJURY, BROKEN COMPONENT FOUND DURING INSTALLATION.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: OUTPUT POWER LOWER THAN EXPECTED DURING INSTALLATION. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606218 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. CYBER TM 200

    Patients

    Seq Age Sex Outcome Treatment
    1