BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1479552 · Received September 22, 2009

    Report

    Report Number
    2090040-2009-00003
    Event Type
    Malfunction
    Date Received
    September 22, 2009
    Date of Event
    August 30, 2009
    Report Date
    September 22, 2009
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NKX
    PMA / PMN Number
    K050518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHACO TIP WAS VISUALLY INSPECTED AND FOUND TO HAVE BROKEN ACROSS THE ABS PORT OF THE PHACO TIP. THE MOST PROBABLE CAUSE OF THE DEVICE FAILURE IS DUE TO FATIGUE. THE FATIGUE IS FROM THE ULTRASONIC ENERGY AND CAUSED A CRACK TO FORM OR PROPAGATED A PRE-EXISTING CRACK TO FRACTURE. THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. DUE TO THE INFREQUENCY OF THIS TYPE OF EVENT, NO TREND ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE TIP OF THE PHACO BROKE OFF. AT THE TIME THE TIP HAD NO FLUID UNDER PRESSURE AND WAS LYING ON TOP THE LENSE, AND THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN TIP WITHOUT ISSUE OR HARM OT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NKX NKX ASCENT HEALTHCARE SOLUTIONS 8065740837 825788

    Patients

    Seq Age Sex Outcome Treatment
    1