BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIFROST (R) 10 CRYOSURGICAL PROBE

    MDR report key: 623620 · Received July 19, 2005

    Report

    Report Number
    623620
    Event Type
    Malfunction
    Date Received
    July 19, 2005
    Date of Event
    April 5, 2005
    Report Date
    July 19, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGIFROST (R) 10 CRYOSURGICAL PROBE WAS TAKEN FROM PACKAGING AS EQUIPMENT WAS BEING SET UP FOR CARDIAC SURGERY CASE. PROBE WAS PLUGGED IN, PIN WAS PULLED BUT CONSOLE WOULD NOT REGISTER PROBE. SECOND PROBE WAS USED WHICH WORKED PERFECTLY IN SAME CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIFROST (R) 10 CRYOSURGICAL PROBE CRYO-ABLATION CATHETER LPB CRYOCATH TECHNOLOGIES INC * 41112

    Patients

    Seq Age Sex Outcome Treatment
    1 *