BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3127509 · Received May 21, 2013

    Report

    Report Number
    2523835-2013-00069
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HNN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED. EVAL OF THE SAMPLE SHOWED THE FOLLOWING RESULTS: THE SAMPLE WAS EXAMINED USING 10X MAGNIFICATION AND FOUND TO HAVE DAMAGED CUTTING EDGES. 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 THE MANUFACTURER'S ACCEPTANCE CRITERIA. HOW OR WHEN THE BLADE BECAME DAMAGED CANNOT BE DETERMINED. THE DAMAGE TO THE RETURNED SAMPLE IS CONSISTENT WITH DAMAGE THAT CAN OCCUR WHEN THE BLADE CONTACTS ANOTHER SURFACE PRIOR TO USE. SOME POTENTIAL CAUSES COULD BE REUSE, IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SETUP. 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A DULL KNIFE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225307 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON MANUFACTURING, LTD. 8065982665 893943M

    Patients

    Seq Age Sex Outcome Treatment
    1