BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE SPRAY CRYOTHERAPY SYSTEM

    MDR report key: 12132050 · Received July 7, 2021

    Report

    Report Number
    1528319-2021-00026
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    April 21, 2021
    Report Date
    July 7, 2021
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    GEH
    PMA / PMN Number
    K172041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY PERSONNEL RESTARTED THE TRUFREEZE SYSTEM AND THE SYSTEM WAS FOUND TO BE OPERATING PROPERLY. THE SYSTEM WAS USED FOR THE NEXT PROCEDURE WHICH WAS COMPLETED SUCCESSFULLY. DUE TO THE REPORTED INTERMITTENT SUCTION, A STERIS SERVICE SPECIALIST WAS DISPATCHED AND REPLACED THE DIGITAL OUTPUT MODULE, ANALOG OUTPUT MODULE, AND KNF PUMP ASSEMBLY. THE SPECIALIST TESTED THE SYSTEM, CONFIRMED IT TO BE OPERATING PROPERLY, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE TRUFREEZE SYSTEM SUCTION WAS INTERMITTENT PRIOR TO START OF THE PROCEDURE, LEADING TO POSTPONEMENT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029518 TRUFREEZE SPRAY CRYOTHERAPY SYSTEM CRYOTHERAPY SYSTEM GEH UNITED STATES ENDOSCOPY GROUP, INC. CC301

    Patients

    Seq Age Sex Outcome Treatment
    1