BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS 3000

    MDR report key: 103003 · Received June 20, 1997

    Report

    Report Number
    1218402-1997-00024
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 20, 1997
    Manufacturer
    SPEMBLY MEDICAL LTD
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CRYOSURGICAL SYSTEM WAS NOTED TO HAVE A CRACKED THAW HEAT EXCHANGER. IF THIS WERE TO OCCUR DURING A PROCEDURE (WHICH IT DIDN'T) IT WOULD BE POSSIBLE THAT LESS THAN ADEQUATE HEAT WOULD BE DEVELOPED IN THE THAW CYCLE. THIS MAY REQUIRE AN EXTENDED TIME TO THAW THE PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3000 CRYOSURGICAL DEVICE GEH SPEMBLY MEDICAL LTD LCS 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other