BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE

    MDR report key: 3879982 · Received February 11, 2014

    Report

    Report Number
    2523835-2014-00023
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Report Date
    January 17, 2014
    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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLES WERE RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. SOME POTENTIAL CAUSES ARE IMPROPER HANDLING, OR CONTACT WITH ANOTHER INSTRUMENT. ALL KNIVES ARE 100% INSPECTED BY TRAINED OPERATORS USING A MINIMUM OF 10X MAGNIFICATION DURING MANUFACTURING. ANY DEFECTS, SUCH AS DAMAGED TIPS AND CUTTING EDGES, ARE REMOVED FORM THE LOT AND SCRAPPED. NO ADD'L ACTION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A DULL KNIFE WAS EXPERIENCED WITH UNKNOWN PROCEDURE OR PATIENT INVOLVEMENT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89800 KNIFE MANUAL OPHTHALMIC SURGICAL INSTRUMENT HNN ALCON PRECISION DEVICE - SINKING SPRING UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1