BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1832363 · Received September 3, 2010

    Report

    Report Number
    2523835-2010-00092
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 5, 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

    SAMPLES HAVE BEEN REC'D AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "BLUNT KNIVES" (DULL). A CUSTOMER REPORTED THE SURGEON WAS UNABLE TO COMPLETE THE MAIN INCISION INTO THE EYE, DUE TO A BLUNT KNIFE, AND A NEW KNIFE HAD TO BE OPENED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT. HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992648 787376M

    Patients

    Seq Age Sex Outcome Treatment
    1