BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 16437367 · Received February 23, 2023

    Report

    Report Number
    MW5115160
    Event Type
    Injury
    Date Received
    February 23, 2023
    Date of Event
    February 17, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ROHRER AESTHETICS, LLC
    Product Code
    ONG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN USING THE ROHRER PHOENIX CO2 LASER IN SCAN MODE, THE LASER PAUSED WHEN MAKING ITS FRACTIONAL SCAN AND STUCK IN ONE SPACE. IT LOOKED LIKE THE SCAN HAD STOPPED AND THAT IT WAS JUST A GUIDE LASER, BUT IN LESS THAN A SECOND I SAW SMOKE FROM THE PATIENT'S NOSE. MY FOOT WAS NOT DEPRESSED ON THE PEDAL, AND WHEN I MOVED THE LASER OFF OF THEIR NOSE/FACE IT LEFT A STREAK ACROSS THE FACE AND SMALL BURN ON THE NOSE. WE WILL FIND OUT LATER IF IT CAUSES ANY PERMANENT SCARRING OR DISCOLORATION. ONCE I HAD THE LASER OFF OF THEIR FACE AND POINTED TOWARD MY TREATMENT TABLE, I TRIED TO HIT THE STANDBY BUTTON WHICH WOULDN'T RESPOND SO, I IMMEDIATELY HIT THE EMERGENCY SHUT OFF BUTTON. I ATTEMPTED TO CONTACT THE MANUFACTURE BUT THEY DID NOT HAVE ANYONE AVAILABLE TO TAKE THE CALL. WE DID NOT PROCEED WITH THE CO2 TREATMENT AFTER THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856570 PHOENIX POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT ONG ROHRER AESTHETICS, LLC PHOENIX 15

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female