BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOLAZER

    MDR report key: 22384929 · Received July 2, 2025

    Report

    Report Number
    3031944951-2025-00002
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    March 12, 2025
    Report Date
    July 1, 2025
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    UDI-DI
    00860564000355
    PMA / PMN Number
    K192583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY QUIT CORRESPONDING AFTER A REPLACEMENT DEVICE WAS SENT TO THEM. MULTIPLE ATTEMPTS, THROUGH PHONE CALLS, VOICE MAIL, ELECTRONIC EMAIL WERE SENT TO REQUEST DAMAGED DEVICE BE RETURNED TO ROHRER AESTHETICS. ALTHOUGH WE CONSIDER THIS CASE CLOSED, AS NO CONFIRMATION CAN BE MADE ON THE FAULTY DEVICE, WE WILL RE-OPEN AND INVESTIGATE THE PRODUCT IF AND WHEN IT IS RETURNED.

    Additional Manufacturer Narrative · 0

    REPLACEMENT OF THE DEVICE WAS SENT IMMEDIATELY TO USER FACILITY; HOWEVER, THE CUSTOMER HAS FAILED TO RETURN THE DAMAGED DEVICE FOR INVESTIGATION. WE WILL CONTINUE TO COMMUNICATE WITH CUSTOMER TO OBTAIN THE DAMAGED DEVICE TO COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 0

    FOLLOW UP REPORT AND CLOSE CASE FOR ORIGINAL 3031944951-2025-00002.

    Description of Event or Problem · 0

    CUSTOMER IVITA WELLNESS MADE CLAIMS THAT AFTER CLEANING THE PICO HANDPIECE, A "BALL OF FLAME" WAS CREATED WHEN THE MACHINE WAS TURNED ON, CRACKING THE LENSE AND MAKING THE DEVICE UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176617 PICOLAZER POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC. PICOLAZER 00860564000355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown