BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3870074 · Received April 29, 2014

    Report

    Report Number
    2523835-2014-00058
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 10, 2014
    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
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED BY MFG FOR EVAL. 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. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. SHARPNESS TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. ADDITIONAL INFO WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT UNSHARP KNIVES WERE NOTED DURING FOUR SEPARATE SURGERIES. ALTERNATE KNIVES WERE OBTAINED IN ORDER TO COMPLETE EACH SURGERY. THERE WAS NO IMPACT TO ANY PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256581 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992445 946604M

    Patients

    Seq Age Sex Outcome Treatment
    1