BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2172427 · Received June 24, 2011

    Report

    Report Number
    2523835-2011-00094
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Report Date
    May 25, 2011
    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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SAMPLE WAS EXAMINED USING 10X MAGNIFICATION AND FOUND TO BE CONFORMING. THE SAMPLE WAS TESTED FOR PENETRATION AND FOUND TO BE CONFORMING. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THIS LOT MET SPEC. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY'S ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SENT IN A REPLY CARD REPORTING A DULL KNIFE WAS NOTED DURING SURGERY. THERE WAS NO PT IMPACT OR ADD'L TREATMENT NEEDED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992445 836988M

    Patients

    Seq Age Sex Outcome Treatment
    1