BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2111136 · Received May 26, 2011

    Report

    Report Number
    2523835-2011-00050
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    April 26, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVALUATION 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THIS LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A BLUNT KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURE ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE KNIVES OUT OF THE PAK WERE BLUNT. ADDITIONAL INFORMATION PROVIDED INDICATED THE EVENT OCCURRED DURING A PROCEDURE, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065993047 795861M

    Patients

    Seq Age Sex Outcome Treatment
    1