BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1058784 · Received June 9, 2008

    Report

    Report Number
    2090040-2008-00003
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NKX
    PMA / PMN Number
    K050518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED DEVICE HAS BEEN RETURNED, HOWEVER, A DEVICE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BEFORE THE PROCEDURE STARTED, THE PHACO TIP WAS NOT OSCILLATING AND BROKE OFF. THE TIP FELL INTO PATIENT'S EYE AND WAS RETRIEVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NKX ASCENT HEALTHCARE SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1