BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE, CRYOCARE CRYOPROBE 1.7MM RIGHT ANGLE

    MDR report key: 3163423 · Received June 11, 2013

    Report

    Report Number
    3008262715-2013-00012
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    August 6, 2013
    Manufacturer
    HEALTHTRONICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K011074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED AND INITIAL EVALUATION BEGUN. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED. FOLLOW-UP ON PATIENT'S CURRENT CONDITION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(6) 2011. DEVICE EVALUATION CONFIRMED VACUUM SLEEVE FAILURE.

    Description of Event or Problem · 1

    SHAFT FROSTING PRECONIZED BETWEEN 1 - 2 MINUTES. LED TO SMALL 1.5CM SKIN BURN. CHANGED PROBE AND CONTINUED. ADDITIONAL INFORMATION RECEIVED VIA CONVERSATION BETWEEN SALES MANAGER AND PHYSICIAN; TESTED PROBE AS REQUIRED, DID NOT SEE FROSTING SO STARTED PROCEDURE. DURING PROCEDURE, PROBE FROSTED UP THE SHAFT AND NOTICED A DIME (1.5CM) SIZED BURN ON SKIN. DRESSED BURN AND WILL FOLLOW-UP. NO SKIN BREAKDOWN. SALES MANAGER PROVIDED PHYSICIAN GUIDANCE ON WHAT TO DO IF FROSTING OCCURS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264695 ENDOCARE, CRYOCARE CRYOPROBE 1.7MM RIGHT ANGLE UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC. PERC-17 4557

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention