BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICASSO

    MDR report key: 2887539 · Received December 14, 2012

    Report

    Report Number
    MW5028294
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 14, 2012
    Manufacturer
    AMD LASERS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Description of Event or Problem · 1

    THE WIRELESS FOOT PEDAL ON PICASSO LASER "FROM AMD LASERS" ACTIVATES ALL THE LASER IN THE SAME OPERATORY. YOU PRESS ONE WIRELESS FOOT PEDAL AND EVERY OTHER LASERS IN THE SAME OPERATORY WILL FIRE SIMULTANEOUSLY. THIS IS DANGEROUS IF YOU HAVE MULTIPLE LASERS IN THE SAME OPERATORY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICASSO PICASSO DIODE LASER GEX AMD LASERS

    Patients

    Seq Age Sex Outcome Treatment
    1 DENTAL DIODE LASER PICASSO BY AMD LASERS