BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2081378 · Received April 22, 2011

    Report

    Report Number
    2523835-2011-00034
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OPENED SAMPLES WERE RETURNED. EVALUATION OF THE SAMPLES SHOWED THE FOLLOWING RESULTS: THE SAMPLES WERE EXAMINED USING 10X MAGNIFICATION AND BOTH WERE 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 TO THE COMPANY'S ACCEPTANCE CRITERIA. BECAUSE THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE IS UNKNOWN, SPECIFIC ACTION WITH REGARD TO THIS COMPLAINT CANNOT BE TAKEN. THERE HAVE BEEN NO CHANGES IN THE MANUFACTURING PROCESS THAT WOULD CONTRIBUTE TO DAMAGED BLADES. ALL KNIVES ARE 100% INSPECTED (B)(4). ANY DEFECTS, SUCH AS THE DAMAGED CUTTING EDGES EXHIBITED ON THE RETURNED OPENED SAMPLES, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION TESTING IS PERFORMED AND MONITORED DURING THE FINISHING PROCESS TO ENSURE THE SHARPNESS OF THE PRODUCT. COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ANY SIGNIFICANT ADVERSE TRENDS. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED AT THE BEGINNING OF A CATARACT SURGERY, WHILE ATTEMPTING TO MAKE THE FIRST INCISION, IT WAS NOTED THAT THE KNIFE WAS NOT SHARP ENOUGH AND THE INCISION COULD NOT BE MADE. THE KNIFE WAS SWITCHED OUT AND A SECOND KNIFE WAS USED FROM THE SAME BATCH AS THE FIRST. THE SECOND KNIFE SHOWED SIMILAR PROBLEMS AND THE SURGEON REPORTED HAVING TO USE AN UNUSUAL AMOUNT OF FORCE TO MAKE A SMALL, SINGLE, INCISION. IN THE END, THE INCISION COULD BE MADE, BUT THE SURGEON NO LONGER WANTED TO USE THE KNIFE. THE PATIENT WAS NOT HARMED IN ANY OTHER WAY THAN THE DELAY OF THE SURGERY (APPROXIMATELY 5 MINUTES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982265 833214M

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR