BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCARE, CRYOCARE CRYOPROBE 3.8MM LONG

    MDR report key: 2870976 · Received December 12, 2012

    Report

    Report Number
    3008262715-2012-00033
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    HEALTHTRONICS, INC.
    Product Code
    GEH
    PMA / PMN Number
    K011074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PROBE LEFT AT THE HOSPITAL BY MISTAKE AND THE HOSPITAL DISPOSED OF IT. DEVICE HISTORY RECORD REVIEW CONDUCTED. NO ISSUES NOTED.THE SHAFT FROSTING FAILURE MODE HAS BEEN INVESTIGATED PREVIOUSLY. PRIOR INVESTIGATION HAS SHOWN THE ROOT CAUSE OF SHAFT FROSTING TO BE A VACUUM SLEEVE FAILURE. (B)(4): DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    DURING PRETEST, THE PROBE TESTED FINE. DURING THE OPEN RENAL CASE, THE PROBE FROSTED ALL THE WAY TO THE HANDLE. BECAUSE THIS WAS AN OPEN CASE AND THE PROBE DID NOT CONTACT THE SKIN, THE PHYSICIAN ELECTED TO CONTINUE USING THE PROBE. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCARE, CRYOCARE CRYOPROBE 3.8MM LONG UNIT, CRYOSURGICAL, ACCESSORIES GEH HEALTHTRONICS, INC. R3.8L 10180

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other