BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSACUT

    MDR report key: 18941409 · Received March 20, 2024

    Report

    Report Number
    2124215-2024-16464
    Event Type
    Death
    Date Received
    March 20, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 20, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, FOLLOWING A PROCEDURE USING THIS DEVICE, THE PATIENT PASSED AWAY. CORRESPONDENCE FROM THE HOSPITAL INDICATED THAT IT WAS SUSPECTED THAT THE DEATH WAS POTENTIALLY RELATED TO INCORRECT DEVICE USE, BUT THIS COULD NOT BE CONFIRMED. THE SUBMITTED REPORT ALSO CLEARLY STATED THAT NO FURTHER INFORMATION WILL BE PROVIDED; THEREFORE, NO EFFORT TO OBTAIN MORE DETAILS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493885 VERSACUT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ LUMENIS LTD UNK-P-VERSACUT_ACCESSORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death