BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3813305 · Received March 28, 2014

    Report

    Report Number
    2523835-2014-00040
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    January 30, 2014
    Report Date
    March 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
    LH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED 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 NURSE REPORTED THAT THE SURGEON TRIED TO MAKE AN INCISION DURING SURGERY, BUT THE KNIFE WAS BLUNT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184805 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992648 922594M

    Patients

    Seq Age Sex Outcome Treatment
    1