BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMEDICS CRYOTIP

    MDR report key: 190709 · Received October 5, 1998

    Report

    Report Number
    1519132-1998-00067
    Event Type
    Malfunction
    Date Received
    October 5, 1998
    Report Date
    September 3, 1998
    Manufacturer
    CRYOMEDICS, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO START OF A CRYOSURGICAL PROCEDURE THE DR NOTICED THAT THE SILVER TIP OF THE CRYOTIP WAS MISSING. THE DR HAS NOT NOTICED WHEN THE SILVER TIP HAD ORIGINALLY SEPARATED FROM THE CRYOTIP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOMEDICS CRYOTIP CRYOSURGICAL PROBE, CONDYLOMA GEH CRYOMEDICS, INC. T-0519 TAGD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN