BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1230805 · Received November 6, 2008

    Report

    Report Number
    2523835-2008-00005
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 1, 2008
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED OPENED SAMPLE AND FOUND TO BE NONCONFORMING FOR A DAMAGED TIP AND CUTTING EDGE. PENETRATION AND SHARPNESS TESTING WERE NOT PERFORMED, DUE TO THE DAMAGED CONDITION OF THE SAMPLE. THE BLADE (EAR) WIDTH WAS MEASURED AND FOUND TO BE CONFORMING FOR THE MEASUREMENT SPECIFICATIONS. QA WAS UNABLE TO DETERMINE HOW STRIPPED DESCEMETS OCCURRED. THE BLADE WIDTH WAS MEASURED AND FOUND TO BE CONFORMING. QA WAS UNABLE TO DETERMINE HOW OR WHEN THE BLADE BECAME DAMAGED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS. ANY DEFECTS, SUCH AS THE DAMAGED TIP AND CUTTING EDGE EXHIBITED ON THE RETURNED OPENED SAMPLE, WOULD BE CULLED FROM THE LOT AND SCRAPPED. PENETRATION AND SHARPNESS TESTING ARE PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE FUNCTIONAL QUALITY OF THE PRODUCT.

    Description of Event or Problem · 1

    SURGEON REPORTED SEVERAL OCCURRENCES WHERE THE BLADE WAS VERY INCONSISTENT, AND HAS STRIPPED DESCEMETS. ADDITIONAL INFORMATION WAS RECEIVED ON 10/08/2008. THE SURGEON INDICATED THAT ALL PATIENTS' OUTCOMES WERE GOOD AND NO VISUAL DISTURBANCE OR LONG TERM COMPLICATION RESULTED. THE SURGEON STATED THAT NO PATIENT IDENTIFIERS / INFORMATION WOULD BE PROVIDED. THE SURGEON STATED THAT HER PRIMARY CONCERN IS THAT THE KNIFE SHARPNESS IS NOT ALWAYS CONSISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065983065 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1