BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1760893 · Received July 14, 2010

    Report

    Report Number
    2523835-2010-00058
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO IMPACT REPORTED." (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "KNIVES ARE DULL" (DULL). THE SURGEON REPORTED THAT THE SURGICAL KNIVES ARE DULL. NO PT IMPACT WAS REPORTED. ADDITIONAL FOLLOW-UP INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992648 795136M

    Patients

    Seq Age Sex Outcome Treatment
    1