BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2161016 · Received June 17, 2011

    Report

    Report Number
    2523835-2011-00076
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 20, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED FOR EVALUATION AND ANALYSIS. VISUAL EXAMINATION USING MAGNIFICATION REVEALED DAMAGE TO THE TIP. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT WAS REVIEWED. FUNCTIONAL PENETRATION TEST VALUES FOR THIS 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. THE ROOT CAUSE FOR THE DAMAGED KNIFE IS UNKNOWN. IT IS UNLIKELY THAT THE DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A PROCEDURE THE SURGEON NOTED THE KNIFE BLADE WAS DULL. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065921540 833815M

    Patients

    Seq Age Sex Outcome Treatment
    1