BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBER HO 100

    MDR report key: 16610003 · Received March 24, 2023

    Report

    Report Number
    3004378299-2023-00001
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    November 25, 2022
    Report Date
    March 24, 2023
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K192600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT WORKING DURING A SURGICAL PROCEDURE. HAEMORRHAGE REQUIRING TRANSFUSION HAPPENED DURING THE PROCEDURE. IT HASN'T BEEN ESTABLISHED YET IF THERE IS A CORRELATION BETWEEN LASER UNAVAILABILITY AND PATIENT HAEMORRHAGE. AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Description of Event or Problem · 0

    DEVICE NOT WORKING DURING A SURGICAL PROCEDURE. HAEMORRHAGE REQUIRING TRANSFUSION HAPPENED DURING THE PROCEDURE. IT HASN'T BEEN ESTABLISHED YET IF THERE IS A CORRELATION BETWEEN LASER UNAVAILABILITY AND PATIENT HAEMORRHAGE. AN INVESTIGATION HAS BEEN OPENED TO OBTAIN MORE INFORMATION ABOUT THE EVENT DYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583960 CYBER HO 100 SURGICAL LASER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization