BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMENIS MOSES 550 D\F\L

    MDR report key: 18984007 · Received March 26, 2024

    Report

    Report Number
    2124215-2024-17520
    Event Type
    Death
    Date Received
    March 26, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 6, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    UDI-DI
    07290109143453
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER (FIRST NAME), E1 INITIAL REPORTER (LAST NAME), E3 OCCUPATION AND E2 HEALTH PROFESSIONAL WERE CORRECTED. THE FOLLOWING FIELDS HAVE BEEN APPROXIMATED AS THE EXACT DATE WAS NOT AVAILABLE: FIELD (B2) DATE OF DEATH. FIELD (B3) DATE OF EVENT. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED AFTER A PROCEDURE USING THIS DEVICE. BASED ON THE PHYSICIAN ASSESSMENT, THE DEVICE WAS NOT A CONTRIBUTING FACTOR TO THE REPORTED PATIENT DEMISE. NO FURTHER INFORMATION IS AVAILABLE. THE PHYSICIAN HAS EXPRESSED A PREFERENCE TO NOT BE CONTACTED IN REGARD TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED AFTER A PROCEDURE USING THIS DEVICE. BASED ON THE PHYSICIAN ASSESSMENT, THE DEVICE WAS NOT A CONTRIBUTING FACTOR TO THE REPORTED PATIENT DEMISE. NO FURTHER INFORMATION IS AVAILABLE. THE PHYSICIAN HAS EXPRESSED A PREFERENCE TO NOT BE CONTACTED IN REGARD TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED AFTER A PROCEDURE USING THIS DEVICE. BASED ON THE PHYSICIANS ASSESSMENT, THE DEVICE WAS NOT A CONTRIBUTING FACTOR TO THE REPORTED PATIENTS DEMISE. NO FURTHER INFORMATION IS AVAILABLE. THE PHYSICIAN HAS EXPRESSED A PREFERENCE TO NOT BE CONTACTED IN REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060754 LUMENIS MOSES 550 D\F\L POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD 1912-10 07290109143453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death