BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBER HO 150

    MDR report key: 18786855 · Received February 27, 2024

    Report

    Report Number
    3004378299-2024-00002
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 27, 2024
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K201455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    STAFF MEMBER RECEIVED AN ELECTRIC SHOCK WHILST WORKING WITH THIS MACHINE (HAND INJURY). AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Description of Event or Problem · 0

    STAFF MEMBER RECEIVED AN ELECTRIC SHOCK WHILST WORKING WITH THIS MACHINE (HAND INJURY). AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670571 CYBER HO 150 SURGICAL LASER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other