BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2161044 · Received June 17, 2011

    Report

    Report Number
    2523835-2011-00075
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 18, 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
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION AND SHARPNESS TEST VALUES FOR THE LOT MET SPECIFICATION. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO A DULL KNIFE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO MANUFACTURER'S ACCEPTANCE CRITERIA. A ROOT CAUSE COULD NOT BE IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A DULL BLADE CAME INTO CONTACT WITH A PATIENT DURING A CATARACT EXTRACTION PROCEDURE. ADDITIONAL INFORMATION PROVIDED INDICATED THE SURGEON EXPRESSED DISSATISFACTION WITH THE INCISION AS A RESULT OF THE BLADE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THIS IS THE FIRST OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992645 836217M

    Patients

    Seq Age Sex Outcome Treatment
    1