BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS MOSES 200 D\F\L

    MDR report key: 21366163 · Received February 12, 2025

    Report

    Report Number
    2124215-2025-07653
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 14, 2025
    Report Date
    June 3, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109143170
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETED UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMED ALLEGATION CANNOT BE CONFIRMED. THE PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATE WITH THE DEVICE TYPE, AND IT IS NOTED AS SUCH IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A URETEROSCOPY, THE FIBER BROKE IN THE MIDDLE OF THE CASE AND CAUSED HOLES IN THE THUMBS OF THE RESIDENT PHYSICIAN. THE FIBER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THE PATIENT OUTCOME WAS UNKNOWN, AND THE RESIDENT PHYSICIAN VISITED THE HEALTH CLINIC DUE TO THE INJURY SUFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A URETEROSCOPY, THE FIBER BROKE IN THE MIDDLE OF THE CASE AND CAUSED HOLES IN THE THUMBS OF THE RESIDENT PHYSICIAN. THE FIBER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THE PATIENT OUTCOME WAS UNKNOWN, AND THE RESIDENT PHYSICIAN VISITED THE HEALTH CLINIC DUE TO THE INJURY SUFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794168 LUMENIS MOSES 200 D\F\L POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD 1912-10 07290109143170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O