BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFREEZE

    MDR report key: 14041943 · Received April 7, 2022

    Report

    Report Number
    14041943
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    November 8, 2021
    Report Date
    March 10, 2022
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRYO SPRAY CATHETER, SNAPPED INTO 2 PIECES BETWEEN THE CRYO MACHINE AND THE BIOPSY PORT OF THE BRONCHOSCOPY SCOPE, SCOPE REMOVED FROM THE PATIENT IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919192 TRUFREEZE UNIT, CRYOSURGICAL, ACCESSORIES GEH CSA MEDICAL, INC. CD3-001 1506

    Patients

    Seq Age Sex Outcome Treatment
    1 20805 DA Female