BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS 3000

    MDR report key: 93077 · Received May 22, 1997

    Report

    Report Number
    1218402-1997-00019
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    May 7, 1997
    Report Date
    May 22, 1997
    Manufacturer
    SPEMBLY MEDICAL LTD
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NEAR THE CONCLUSION OF THE CRYOSURGICAL PORTION OF A LIVER RESECTION PROCEDURE, THE DR HEARD WHAT HE BELIEVED TO BE A HOSE BURST WITHIN THE LCS 3000 SYSTEM. THERE WERE NO PT COMPLICATIONS. A SUBSEQUENT REPAIR OF THE SYSTEM INDICATED AN INTERNAL FREEZE PORT WITHIN THE SYSTEM.

    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 79 YR Other