BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232309 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00021
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    August 20, 2012
    Report Date
    December 19, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERFACE BOARD WAS REPLACED AND THE LASER SYSTEM RETURNED TO WORK. WE ARE UNAWARE ABOUT PT INJURY. NOTE: THIS LASER SYSTEM ((B)(4)) IS NOT SOLD IN USA, BUT IT IS SIMILAR TO THE (B)(4) WITH 510(K) K100558.

    Description of Event or Problem · 1

    THE LASER SYSTEM SHOWED INTERLOCK ERROR AND ERROR 1-9. WE ARE UNAWARE ABOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. IG-808

    Patients

    Seq Age Sex Outcome Treatment
    1