BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1811742 · Received August 23, 2010

    Report

    Report Number
    2090040-2010-00008
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ASCENT
    Product Code
    NKX
    PMA / PMN Number
    K050518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 MOST LIKELY FROM THE ULTRASONIC ENERGY AND CAUSED A CRACK TO FORM. DUE TO LOW SALES VOLUME, ASCENT STOPPED REPROCESSING THIS TYPE OF PHACO TIP IN (B)(4) OF 2009. THIS DEVICE WAS REPROCESSED BEFORE ASCENT STOPPED THE REPROCESSING OF THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE PHACO BROKE OFF. THE TIP WAS RETRIEVED AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NKX NKX ASCENT 8065790022 535017SH

    Patients

    Seq Age Sex Outcome Treatment
    1