BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE RENALCRYO

    MDR report key: 5624472 · Received May 3, 2016

    Report

    Report Number
    5624472
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 17, 2016
    Report Date
    April 13, 2016
    Manufacturer
    HEALTHTRONICS, INC
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CRYOABLATION PROBE WAS NOT WELL INSULATED, CREATING A DIME SIZE THERMAL INJURY ON RIGHT LOWER BACK. THIS DEFECT DOES NOT SHOW UP ON THE SHAFT DURING THE TEST AS IT TOOK A FEW MINUTES TO SEE IT ONCE THE PROBE WAS REMOVED AND RETESTED AWAY FROM THE PATIENT. COMPANY NOTIFIED AND ASKED WHAT STEPS SHOULD BE TAKEN SO THIS DOESN'T HAPPEN AGAIN. PHOTOS OF PROBE OBTAINED. MANUFACTURER RESPONSE FOR CRYOPROBE, ENDOCARE TM 1.7MM LONG SHAFT RENALCRYOTM CRYOPROBE OBLONG ICE (PER SITE REPORTER): REPLACING AT NO CHARGE, FOLLOWING UP ON THEIR END WITH AN INVESTIGATION OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284312 ENDOCARE RENALCRYO UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC 1.7 18149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other