BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 18619906 · Received January 31, 2024

    Report

    Report Number
    3012236936-2024-00252
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 31, 2024
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED SITE AND REPLACED THE JOYSTICK. FSE ALSO REPORTED THAT THERE WAS NO PATIENT INTERVENTION. SYSTEM CHECKOUT PASSED. SYSTEM MEETS ALL SPECIFICATIONS. MANUFACTURING RECORDS REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPRING BROKE ON THE JOYSTICK AND CAN'T FIND NEUTRAL. IT KEEPS GOING UP OR GOING DOWN AND NOT STOPPING WITH PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WAS NO PATIENT INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414738 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown