BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE+

    MDR report key: 19226121 · Received May 1, 2024

    Report

    Report Number
    1222993-2024-00021
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    February 16, 2023
    Report Date
    May 1, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    UDI-DI
    00841494100063
    PMA / PMN Number
    K142376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE CONTRACT MANUFACTURING SITE REPORTING AN UNINTENDED DISCHARGE OF LASER ENERGY, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

    Description of Event or Problem · 0

    ON 24 APR 2024, CONTRACT MANUFACTURER COGMEDIX REPORTED TO CYNOSURE AN ACCIDENTAL RADIATION OCCURRENCE (ARO), WHICH OCCURRED DURING THE MANUFACTURING ASSEMBLY PROCESS OF ELITE+ SN (B)(6) ON 16 FEB 2023. DURING THE ASSEMBLY PROCESS, THE YAG ROD WAS INSTALLED BACKWARDS AND CAUSED THE LASER TO FIRE BACKWARDS UNEXPECTEDLY. NO INJURIES WERE REPORTED. PER THE PROCEDURE, A PROTECTIVE SHIELD IS TO BE USED DURING THE ASSEMBLY PROCESS AND IT WAS NOT BEING USED AT THE TIME OF THE REPORTED INCIDENT. COGMEDIX HAS INITIATED CORRECTIVE ACTION CA-100634 TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2038435 ELITE+ ELITE+ GEX CYNOSURE LLC 00841494100063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown