BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 1533122 · Received November 19, 2009

    Report

    Report Number
    2090040-2009-00007
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    October 26, 2009
    Report Date
    December 14, 2009
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    NKX
    PMA / PMN Number
    K050518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE HAS NOT BEEN RETURNED TO ASCENT. ONCE THE DEVICE IS RETURNED AN EVALUATION WILL BE COMPLETED. THE CUSTOMER DID NOT HAVE THE ITEM NUMBER OR LOT NUMBER AVAILABLE.

    Description of Event or Problem · 1

    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 HEALTHCARE SOLUTIONS 87065750853 825795SH

    Patients

    Seq Age Sex Outcome Treatment
    1