BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-COAT MICRO HDL KERRISON RONG, THIN

    MDR report key: 1791603 · Received July 28, 2010

    Report

    Report Number
    1423537-2010-00004
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 28, 2010
    Report Date
    July 27, 2010
    Manufacturer
    CAREFUSION
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE INSTRUMENT WAS NOT RECEIVED FOR INVESTIGATION, (THE BROKEN PIECE WAS NOT RECEIVED); THE MISSING PIECE IS CRUCIAL FOR A COMPLETE AND ACCURATE ANALYSIS OF THE CONCERN. A REVIEW OF OUR DHR (DEVICE HISTORY REPORT) AND COMPLAINT HISTORY TRENDING HAS BEEN INITIATED. THE RESULT OF THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. AS APPLICABLE, A CORRECTIVE AND PREVENTIVE ACTION WILL BE INITIATED ONCE THE INFORMATION IS COLLECTED AND REVIEWED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE INFORMATION.

    Description of Event or Problem · 1

    TIP BROKE OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-COAT MICRO HDL KERRISON RONG, THIN RONGEUR HTX CAREFUSION NL4252-84T I09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention