BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3196894 · Received June 26, 2013

    Report

    Report Number
    2523835-2013-00089
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 17, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RETURNED. EVALUATION OF THE SAMPLE SHOWED THE FOLLOWING RESULTS: THE SAMPLE WAS EXAMINED USING (B)(4) MAGNIFICATION AND FOUND TO HAVE A DAMAGED TIP AND 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 MANUFACTURER'S ACCEPTANCE CRITERIA. THE EXACT ROOT CAUSE FOR THE DAMAGED KNIFE IS UNK; 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 PERCENT INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF (B)(4) MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS THE DAMAGED TIP AND CUTTING EDGES EXHIBITED ON THE RETURNED OPENED SAMPLE, ARE REMOVED FROM THE LOT AND SCRAPPED. PENETRATION 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 THAT A KNIFE WAS DULL AND WOULD NOT CUT DURING A PROCEDURE. THE CASE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291573 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982465 904894M

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARCUT HP2 DB SLIT 2.4MM ANGLED KNIFE