BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S.P.A.

    MDR report key: 3232330 · Received December 21, 2012

    Report

    Report Number
    3004378299-2012-00006
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    August 28, 2012
    Report Date
    December 18, 2012
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K091909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CAPACITOR INSIDE THE LASER SYSTEM EXPLODED WITH RELEASE OF ODOR AND SMOKE. THE CAUSE OF THIS COMPLAINT WAS A DEFECTIVE POWER SUPPLY UNIT THAT WAS DELIVERING EXCESSIVE ENERGY. CAPACITOR BENCH NAD POWER SUPPLY HAVE BEEN SUBSTITUTED AND THE LASER AFTER ALSO A FUNCTIONAL AND PERFORMANCE CHECK HAS BECAME AGAIN FULLY OPERATIONAL.

    Description of Event or Problem · 1

    HOLMIUM SURGICAL LASER. DURING TREATMENT THE DEVICE MADE A POPPING SOUND AND WHITE SMOKE APPEARED THROUGH THE COOLING FAN. THE LASER WAS IMMEDIATELY UNPLUGGED AND REMOVED FROM THE OPERATING ROOM. THE SURGEON USED A PNEUMATIC LITHOCAST TO CONTINUE THE PROCEDURE. THE DEVICE WAS RETURNED TO DISTRIBUTOR FOR THE INSPECTION AND REPAIR. NO 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. LIGHO

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR