BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM SPA

    MDR report key: 3232317 · Received December 18, 2012

    Report

    Report Number
    3004378299-2011-00019
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    May 24, 2011
    Report Date
    December 14, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K090962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    REPLACED FOOTSWITCH STUCKED THAT GIVES ALARMS DURING START-UP SEQUENCE OR DURING ANY CHANGE BETWEEN STAND-BY AND READY CONDITIONS. THE EVENT DID NOT CREATE INJURY TO THE PATIENT BECAUSE DID NOT HAPPENED DURING A SURGICAL INTERVENTION. WE ARE NOT AWARE ABOUT EVENTUAL DELAY OF SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    FOOT PEDAL STUCKING IN ON POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTA SYSTEM SPA POWERED LASER SURGICAL DEVICE, PRODUCT CODE: GEX GEX QUANTA SYSTEM, S.P.A. CYBER TM 120

    Patients

    Seq Age Sex Outcome Treatment
    1