BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3043015 · Received March 7, 2013

    Report

    Report Number
    2523835-2013-00023
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 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
    NC, US
    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 10X MAGNIFICATION AND FOUND TO HAVE A DAMAGED TIP AND CUTTING EDGE. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. 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. ALL KNIVES ARE 100 PERCENT INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS THE DAMAGED TIP AND CUTTING EDGE 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

    AN OPERATING ROOM MANAGER REPORTED TWO DULL BLADES WERE NOTED DURING A PROCEDURE. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98513 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065992445 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1