BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 4912767 · Received July 10, 2015

    Report

    Report Number
    3004378299-2015-00060
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 23, 2015
    Report Date
    September 7, 2015
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K130256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE INITIALLY SENT WRONG PRODUCT DATA INFORMATION INTO OUR 3004378299-2015-00060 MDR MEDWATCH FORM 3500A SENT ON 07/10/2015. CONSIDERING THE CORRECTED PRODUCT DATA, THE EVENT IS NO MORE CONSIDERED TO BE REPORTED TO FDA. THE RIGHT DATA IS NOW FILLED INTO THIS FOLLOW-UP FORM, WHILE THE PREVIOUS (WRONG) DATA IS LISTED BELOW. FIRST SENT DATA (BEFORE THE CORRECTIONS INTRODUCED BY THIS FOLLOW-UP): MODEL: CYBER TM 150, S/N (B)(4), 510(K): K131081.

    Additional Manufacturer Narrative · 1

    WE ARE WAITING FOR ADDITIONAL INFORMATION. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "PROBLEMS DURING FREQUENCY SETTINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448388 QUANTA SYSTEM S.P.A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. Q-PLUS 1

    Patients

    Seq Age Sex Outcome Treatment
    1