BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS5

    MDR report key: 82690 · Received April 7, 1997

    Report

    Report Number
    82690
    Event Type
    Injury
    Date Received
    April 7, 1997
    Date of Event
    March 10, 1997
    Report Date
    April 7, 1997
    Manufacturer
    SPEMBLY MEDICAL LTD.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE THE PROBE WAS BEING DISCONNECTED FROM THE SYSTEM AT THE CONCLUSION OF A CRYOSURGERY CASE, SOME LIQUID NITROGEN ESCAPED FROM THE CONNECTOR PORT. SOME LIQUID NITROGEN STRUCK THE NURSES GLOVE AND FROZE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CS5 CRYOSURGICAL DEVICE DSP SPEMBLY MEDICAL LTD. CS-5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention