BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 1940507 · Received December 17, 2010

    Report

    Report Number
    2523835-2010-00151
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVAL; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. A LOT HISTORY SEARCH COULD NOT BE DONE BECAUSE OF THE INFO THAT WAS PROVIDED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE BLUNT KNIFE EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. THE MOST LIKELY CAUSE OF BLUNTNESS IS DAMAGE TO BLADE. HOWEVER, IT IS UNLIKELY THAT DAMAGE OCCURRED DURING THE MFG PROCESS. SOME POTENTIAL CAUSES ARE REUSE, IMPROPER HANDLING BY THE CUSTOMER, IMPROPER HANDLING DURING SHIPPING, OR CONTACT WITH ANOTHER INSTRUMENT ON THE INSTRUMENT TRAY DURING PROCEDURE SETUP. BECAUSE THE ROOT CAUSE IS UNK AND NO MALFUNCTIONS WERE CONFIRMED, NO SIMILAR INCIDENTS CAN BE IDENTIFIED. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MFG. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, 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 SURGEON REPORTED THAT THE KNIVES DON'T ALWAYS HAVE THE SAME SHARPNESS. THE SURGEON STATED OCCASIONALLY SHE ENCOUNTERS A KNIFE THAT ISN'T SHARP ENOUGH. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT. HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1