BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3112085 · Received May 7, 2013

    Report

    Report Number
    2523835-2013-00061
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 12, 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 Location
    CA
    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 TIPS AND CUTTING EDGES. ONE OF THE SAMPLES' TIPS WAS BENT OVER 180 DEGREE. 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 KNIVES IS UNKNOWN; HOW OR WHEN THE BLADES BECAME DAMAGED CANNOT BE DETERMINED. THE DAMAGE TO THE RETURNED SAMPLES 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 THE DAMAGED TIPS AND 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER RETURNED TWO KNIVES, REPORTING THAT THEY WERE DULL. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT NO PATIENTS WERE HARMED AS A RESULT OF THE DULL BLADES; IN EACH CASE AN ALTERNATE BLADE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199921 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982465 908652M

    Patients

    Seq Age Sex Outcome Treatment
    1