BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOCARE CRYOCARE URETHRAL WARMING SYSTEM

    MDR report key: 7993260 · Received October 22, 2018

    Report

    Report Number
    3008262715-2018-00036
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    April 23, 2018
    Report Date
    November 7, 2018
    Manufacturer
    ENDOCARE INC.
    Product Code
    GEH
    PMA / PMN Number
    K153489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION AND INVESTIGATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS INFORMED BY THE TECHNICIAN THAT THERE ARE TWO URETHRAL WARMING SYSTEMS (UWS) THAT COULD HAVE POTENTIALLY BEEN USED AS THEY ARE OFTEN SWAPPED BETWEEN CRYOABLATION SYSTEMS, THEREFORE BOTH UWS WERE TESTED AS IT WAS UNCLEAR WHICH WAS USED ON THE DAY OF THE TREATMENT. S/N (B)(4) & S/N (B)(4) WERE TESTED BY PERFORMING A MANUFACTURER INSPECTION PROCEDURE AND COMPLETING A PREVENTIVE MAINTENANCE PROCEDURE. BOTH SUSPECTED DEVICES (S/N (B)(4) AND S/N (B)(4)) WERE TESTED AND FOUND TO BE OPERATING WITHIN RANGE OF MANUFACTURER'S SPECIFICATION. FIELD SERVICE MANAGEMENT REVIEWED ALL DOCUMENTATION CREATED IN VALIDATING, VERIFYING AND APPROVING THE CHANGE FROM THE PREVIOUS WARMER TO THE NEW WARMER, NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    URETHRAL SLOUGHING. RECEIVED A CALL FROM HEALTHTRONICS INDICATING DOCTOR WAS QUESTIONING WHETHER THE NEW WARMERS ARE AS EFFECTIVE AS THE OLD WARMERS HE'D BEEN USED TO. THE OLD WARMERS COULD BE DIALED UP TO DISPLAY 43 DEGREES AND THE NEW WARMERS CANNOT BE CHANGED AND DISPLAY 40. THIS IS STEMMING FROM A SECOND TREATMENT WHERE THE DOCTOR REPORTED URETHRAL SLOUGHING. THE FIRST TREATMENT WAS ON (B)(6) 2018 AND REPORTED ON 3008262715-2018-00009 / (B)(4).

    Description of Event or Problem · 1

    URETHRAL SLOUGHING. RECEIVED A CALL FROM HEALTHTRONICS INDICATING DOCTOR WAS QUESTIONING WHETHER THE NEW WARMERS ARE AS EFFECTIVE AS THE OLD WARMERS HE'D BEEN USED TO. THE OLD WARMERS COULD BE DIALED UP TO DISPLAY 43 DEGREES AND THE NEW WARMERS CANNOT BE CHANGED AND DISPLAY 40. THIS IS STEMMING FROM A SECOND TREATMENT WHERE THE DOCTOR REPORTED URETHRAL SLOUGHING. THE FIRST TREATMENT WAS ON (B)(6) 2018 AND REPORTED ON 3008262715-2018-00009 / PC18-0027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830155 ENDOCARE CRYOCARE URETHRAL WARMING SYSTEM UNIT, CRYOSURGICAL, ACCESSORIES GEH ENDOCARE INC. CRYO-63 R16271-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other