BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS LTD.

    MDR report key: 20466543 · Received October 16, 2024

    Report

    Report Number
    2124215-2024-62865
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 20, 2024
    Report Date
    December 6, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109145457
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERROR DISPLAYED WHEN OUTPUT WAS ATTEMPTED. AFTER FIFTEEN MINUTES, THE PROCEDURE RESUMED AND COULD BE SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. AFTER THE PROCEDURE, THE PATIENT HAD A FEVER AND DEVELOPED SEPSIS. TO TREAT THE INFECTION, THE PATIENT HAD TO TAKE ANTIBIOTICS, AND HOSPITALIZATION WAS EXTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERROR DISPLAYED WHEN OUTPUT WAS ATTEMPTED. AFTER FIFTEEN MINUTES, THE PROCEDURE RESUMED AND COULD BE SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. AFTER THE PROCEDURE, THE PATIENT HAD A FEVER AND DEVELOPED SEPSIS. TO TREAT THE INFECTION, THE PATIENT HAD TO TAKE ANTIBIOTICS, AND HOSPITALIZATION WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249703 LUMENIS LTD. POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD GA-2003476 0000001533 07290109145457

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| O