BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1885101 · Received October 20, 2010

    Report

    Report Number
    2523835-2010-00113
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Report Date
    September 21, 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
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: THE KERATOME IS PART OF A CUSTOM PAK. THE PAK WAS OPENED AND THE KNIFE REMOVED FROM ITS PACKET. STAFF ARE VERY CAREFUL THAT THE BLADE DOES NOT COME IN CONTACT WITH ITS PACKAGING, THE STERILE DRAPE OR ANYTHING ON THE STERILE TRAY PRIOR TO IT BEING USED. THE KNIFE WAS FOUND TO BE BLUNT AND ANOTHER KNIFE OPENED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL FOLLOW-UP INFORMATION 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 8065992848 806249M

    Patients

    Seq Age Sex Outcome Treatment
    1 SURGICAL PAK| CUSTOM PAK