BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLIAMS LACRIMAL PROBE 00-0

    MDR report key: 1541767 · Received November 6, 2009

    Report

    Report Number
    1423537-2009-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2009
    Date of Event
    October 8, 2009
    Report Date
    November 5, 2009
    Manufacturer
    CAREFUSION
    Product Code
    HNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    YOUR REPORT INDICATED THE DEFICIENCY AS "INSTRUMENT BROKE AT THE TIP DURING SURGERY." THE EFFECTED INSTRUMENT HAS NOT YET BEEN RECEIVED AT OUR FACILITY. A REVIEW OF OUR DHR (DEVICE HISTORY REPORT) AND COMPLAINT HISTORY TRENDING HAS BEEN INITIATED. UPON RECEIPT OF THE INSTRUMENT IT WILL BE EVALUATED AND FORWARDED ON TO MANUFACTURER FOR AN INVESTIGATION INTO THE COMPLAINT. THE RESULT OF THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME, HOWEVER, AS SOON AS ALL INFO IS REVIEWED TO DETERMINE IF A CORRECTIVE AND PREVENTIVE ACTION IS NECESSARY; A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE INFO.

    Description of Event or Problem · 1

    CUSTOMER STATES INSTRUMENT BROKE AT THE TIP DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLIAMS LACRIMAL PROBE 00-0 PROBE HNL CAREFUSION OP7030-300 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Required Intervention