BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVITEC HYDRODISSECTOR

    MDR report key: 5331734 · Received December 29, 2015

    Report

    Report Number
    1211998-2015-00001
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    July 24, 2015
    Report Date
    September 23, 2015
    Manufacturer
    BEAVER VISITEC INTERNATIONAL
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO INITIAL EXPLANATION UNDER THE DESCRIPTION OF THE PROBLEM AND INVESTIGATION NOTES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IRRIGATION CANNULA DETACHED FROM THE SYRINGE WHILE THE SURGEON WAS IRRIGATING THE WOUND. NO PATIENT WAS INJURED. THE PRODUCT CATALOG NUMBER IS 585158 VISITEC HYDROSSECTOR .40MM FLAT END AND LOT NUMBER IS 3119694.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857149 VIVITEC HYDRODISSECTOR VISITEC HYDRODISSECTOR, PRODUCT CODE HMX HMX BEAVER VISITEC INTERNATIONAL 585158 .40MM FLAT END CANNULA 3119694

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA