BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE IQ

    MDR report key: 14758043 · Received June 21, 2022

    Report

    Report Number
    1222993-2022-00024
    Event Type
    Malfunction
    Date Received
    June 21, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 21, 2022
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    UDI-DI
    08057017760450
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ELITE IQ FIRED UNINTENTIONALLY WHILE IN THE HOLSTER AFTER A TREATMENT WAS PERFORMED. NO PATIENT INJURY WAS REPORTED. CLINICAL HAD REACHED OUT TO THE SITE TO DISCUSS LOCKING THE HANDPIECE PRIOR TO PLACING IT INTO THE HOLDER. CUSTOMER REPORTS THAT IT IS LIKELY THAT OPERATORS WERE NOT LOCKING THE HANDPIECE. A DEVICE EVALUATION WAS PERFORMED AND CONFIRMED TO BE OPERATING WITHIN SPECIFICATION. LABELING INSTRUCTS USERS TO ENGAGE FINGERSWITCH LOCK WHEN HANDPIECE IS NOT IN USE TO AVOID UNWANTED LASER EMISSIONS. DUE TO THE SITE REPORTING THAT THE DEVICE WAS FIRING ON ITS OWN, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756738 ELITE IQ ELITE IQ GEX EL. EN. ELECTRONIC ENGINEERING SPA M122B1 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown