BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRIGITRONICS CCS-200

    MDR report key: 712412 · Received April 20, 2006

    Report

    Report Number
    712412
    Event Type
    Malfunction
    Date Received
    April 20, 2006
    Date of Event
    March 14, 2006
    Report Date
    March 16, 2006
    Manufacturer
    COOPERSURGICAL, (FORMERLY: ACKRAD LABORATORIES, INC.)
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING CASE, PHYSICIAN WAS USING STRAIGHT CRYO PROBE. DURING USE OF CRYO MACHINE, A VERY LOUD PRESSURED POP OCCURRED ON THE FIELD. THE TEAM FROZE, ASSESSED THE FIELD, THEN REALIZED THE CRYO PROBE HAD BURST OPEN AT THE SEAM. THE MACHINE WAS IMMEDIATELY TURNED OFF. THE PROBE WAS REMOVED FROM FIELD, ASSESSED FOR ANY MISSING PART/PIECES, NONE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRIGITRONICS CCS-200 PROBE, CRYOTHERAPY GEH COOPERSURGICAL, (FORMERLY: ACKRAD LABORATORIES, INC.) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR