BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2150709 · Received June 22, 2011

    Report

    Report Number
    2523835-2011-00086
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 23, 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
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT THE EVALUATION IS NOT COMPLETE. 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

    A NURSE REPORTED THAT SEVERAL KNIVES WERE FOUND TO BE DULL DURING SURGERY. NO PT IDENTIFIERS WERE PROVIDED AND NO PT HARM WAS REPORTED. THIS IS THE SECOND OF THREE REPORTS FROM THE SAME FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982465 824551M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK