BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-OK OPHTHALMIC KNIVES

    MDR report key: 6181987 · Received December 16, 2016

    Report

    Report Number
    2523835-2016-00929
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    December 16, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    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 RETURNED TO MANUFACTURING FOR EVALUATION OF THIS COMPLAINT FOR DULL BLADES THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT THEREFORE, LOT HISTORY AND COMPLAINT HISTORY REVIEWS COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER INFORMATION IS AVAILABLE THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE EXACT ROOT CAUSE FOR THIS COMPLAINT IS UNKNOWN THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. DEFECTS, SUCH AS DULL AND DAMAGED CUTTING EDGES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS:(B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT MULTIPLE KNIVES APPEARED TO BE BLUNT WHEN EXAMINED UNDER THE MICROSCOPE DURING SEPARATE SURGERIES. THERE WAS NO IMPACT TO ANY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS DECLINED TO BE PROVIDED BY THE REPORTING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833578 A-OK OPHTHALMIC KNIVES KNIFE, OPHTHALMIC HNN ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other