BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYO PLUS

    MDR report key: 541545 · Received March 29, 2004

    Report

    Report Number
    1216677-2004-00005
    Event Type
    Other
    Date Received
    March 29, 2004
    Date of Event
    March 5, 2004
    Report Date
    March 29, 2004
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING A CRYO ABLATION, THE PROBE WOULD NOT DEFROST. THE AREA WAS FLUSHED WITH SALINE TO RELEASE PROBE FROM TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYO PLUS CRYOSURGICAL UNIT GEH COOPERSURGICAL, INC. 2402 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention