BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 2081157 · Received April 14, 2011

    Report

    Report Number
    2523835-2011-00029
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Report Date
    March 15, 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
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THREE OPENED SAMPLES WERE RETURNED FOR EVALUATION AND ANALYSIS. A VISUAL INSPECTION UNDER MAGNIFICATION REVEALED ALL THREE SAMPLES WERE FOUND TO HAVE DAMAGED TIPS 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 MANUFACTURE ACCEPTANCE CRITERIA. ROOT CAUSE FOR THE DAMAGED KNIVES CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING THREE DIFFERENT PROCEDURES, THREE KNIVES WERE FOUND TO BE NOT SHARP ENOUGH TO CUT THROUGH THE CONJUNCTIVA. ANOTHER KNIFE WAS USED TO COMPLETE EACH CASE WITHOUT HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING 8065982665 824586M

    Patients

    Seq Age Sex Outcome Treatment
    1