BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERC-17

    MDR report key: 980225 · Received November 20, 2007

    Report

    Report Number
    2030653-2007-00001
    Event Type
    Malfunction
    Date Received
    November 20, 2007
    Manufacturer
    ENDOCARE, INC.
    Product Code
    GEH
    PMA / PMN Number
    K023757
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOCARE HAS IMPLEMENTED A 100% FUNCTIONAL TEST INSPECTION AT INCOMING QC OF THE INTERNAL COMPONENT RESPONSIBLE FOR THE SHAFT FROSTING CONDITION. ADDITIONALLY, A 100% FINAL FUNCTIONAL INSPECTION HAS BEEN IMPLEMENTED TO DETECT ANY SHAFT FROSTING ON FINISHED PRODUCT PRIOR TO PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERC-17 PROBE, CRYOTHERAPY GEH ENDOCARE, INC. PERC-17 *

    Patients

    Seq Age Sex Outcome Treatment
    1