BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 4152539 · Received October 6, 2014

    Report

    Report Number
    2523835-2014-00162
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    HNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE THAT HAS NOT YET BEEN RECEIVED BY MANUFACTURING FOR EVALUATION. 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 10X 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 INFORMATION WAS REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED UNSPECIFIED PROBLEMS WITH A KNIFE DURING A PROCEDURE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED THROUGH A VIDEO OF THE PROCEDURE WHEREBY THE SUBJECT KNIFE EXHIBITED CUT RESISTANCE DURING THE PROCEDURE. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622291 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921541 961691M

    Patients

    Seq Age Sex Outcome Treatment
    1