BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XEO

    MDR report key: 15612480 · Received October 15, 2022

    Report

    Report Number
    2954354-2022-00005
    Event Type
    Malfunction
    Date Received
    October 15, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 14, 2022
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K153671
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 12-YEAR-OLD XEO LASER SYSTEM INVOLVED IN THE INCIDENT WAS INSPECTED AT A CUTERA FACILITY IN JAPAN BY A CUTERA KK FSE. THE EVENT WAS FOUND TO BE REPRODUCIBLE FOR THE MALFUNCTIONING DEVICE. THE CAUSE OF THE MALFUNCTION WAS TRACED TO A CONTROL PCB THAT HAD BECOME DEFECTIVE. THE DEFECTIVE CONTROL PCB WAS REPLACED, AND THE REPAIRED DEVICE FULLY TESTED. NO RECURRENCE OF THE EVENT WAS SEEN, AND THE DEVICE WAS FOUND TO BE CALIBRATED AND FUNCTIONING CORRECTLY. THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER SITE AND DEFECTIVE CONTROL PCB WAS SENT TO CUTERA'S US MANUFACTURING FACILITY FOR A MORE DETAILED EXAMINATION WITH HOPES OF DETERMINING THE SPECIFIC COMPONENT(S) ON THE CONTROL PCB THAT FAILED AND HOW THE FAILURE(S) ALLOWED THE EMISSION OF AN UNINTENDED SINGLE LASER PULSE AS THE DEVICE WAS TURNED OFF BY THE KEY SWITCH WHILE IN READY MODE WITH THE SAFETY SHUTTER OPEN. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION INTO THE ROOT CAUSE OF THE CONTROL PCB DEVELOPING A DEFECT HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    AFTER COMPLETING A 1064-NM LASER GENESIS TREATMENT WITH A 12-YEAR-OLD XEO LASER SYSTEM, AND WITH THE DEVICE STILL IN READY MODE WHERE THE LASER SAFETY SHUTTER IS INTENTIONALLY OPEN, THE NURSE OPERATOR TURNED THE DEVICE'S KEY SWITCH TO THE OFF POSITION. THE DEVICE MALFUNCTIONED AND A SINGLE HIGH-ENERGY 1064-NM LASER PULSE WAS EMITTED FROM THE TREATMENT HANDPIECE. THE OPERATOR WAS HOLDING THE HANDPIECE IN HER RIGHT HAND WITH IT POINTED TOWARDS HER LEFT THIGH, SO THE UNINTENDED LASER PULSE HIT HER LEFT THIGH CAUSING A HOLE IN HER UNIFORM AND A 5-MM DIAMETER SUPERFICIAL PARTIAL-THICKNESS BURN ON HER UNDERLYING SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665844 XEO DERMATOLOGY LASER GEX CUTERA, INC. XEO

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other