BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOTIP

    MDR report key: 64653 · Received January 21, 1997

    Report

    Report Number
    2522397-1997-00001
    Event Type
    Malfunction
    Date Received
    January 21, 1997
    Date of Event
    December 4, 1996
    Report Date
    January 16, 1997
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO A CRYOSURGICAL PROCEDURE THE CRYOTIP SEPARATED UPON PRESSURIZATION OF THE CRYOGUN. THERE WAS NO PT INJURY. THE REPORTER STATED THAT THE MALFUNCTION COULD HAVE CAUSED PT INJURY IF THE SEPARATION OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOTIP CRYOSURGICAL PROBE GEH CABOT MEDICAL CORP. T-2507 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO