BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MK-2000

    MDR report key: 9320036 · Received November 14, 2019

    Report

    Report Number
    8030392-2019-00003
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 14, 2019
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HNO
    PMA / PMN Number
    K990900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL:MK-2000 IS A DEVICE THAT COMPRISED OF HAND-PIECE SET AND A BLADE. THE BLADE IS AN ACCESSORY (SINGLE USE) THAT CREATES A VALVULAR FLAP BY INCISION THE CORNEA. AFTER INITIAL INFORMATION FROM THE DISTRIBUTOR, THE HAND-PIECE SET WAS RETURNED TO US FOR INVESTIGATION. THERE WERE SCRATCHES ON THE HAND-PIECE. HOWEVER, NO PROBLEM WAS FOUND ON THE FUNCTION. SINCE THE BLADES HAD BEEN DISCARDED AT THE CUSTOMER SIDE, WE COULD NOT PERFORM FURTHER INVESTIGATION. NO INFORMATION FOR THE DEVICE HANDLING AND NO PATIENT INFORMATION WERE PROVIDED. THE DEVICE HAS BEEN USED FOR 17 YEARS. IT HAS BEEN USED SIGNIFICANTLY BEYOND ITS SERVICE LIFE OF 7 YEARS. THEREFORE, THE RETENTION PERIOD (15 YEARS) FOR THE DEVICE MANUFACTURING RECORD HAS BEEN EXCEEDED AND THE DHR COULD NOT BE INVESTIGATED. THERE WAS NO SIMILAR COMPLAINT IN THE PAST SIX MONTHS, AND NO TREND WAS FOUND. MOREOVER, THERE WAS NO COMPLAINT FROM THE CUSTOMER WHO WAS DISTRIBUTED SAME LOT NUMBER OF THE BLADE (LOT#180401). THE INSTRUCTION MANUAL STATES THE PRECAUTION OF THE CREATING THE FLAP AND THE BUTTON-HOLE AS AN ADVERSE EVENT. THE OCCURRENCE OF BUTTON HOLE AS ADVERSE EVENT CAN BE PREVENTED IN ACCORDANCE WITH THE INSTRUCTION MANUAL. NIDEK CONSIDERS THIS ISSUE A REPORTABLE EVENT AS IT HAS A POTENTIAL TO CONTRIBUTE A SERIOUS INJURY.

    Description of Event or Problem · 1

    WE ,NIDEK CO.,LTD., RECEIVED INFORMATION FROM NIDEK'S AUTHORIZED DISTRIBUTOR IN AUSTRALIA THAT THIN FLAP AND BUTTON-HOLE OCCURRED IN TWO CASES USING NIDEK MICROKERATOME MODEL:MK-2000 (S/NO. (B)(4)). IN ADDITION THE SURGERY FOR TWO PATIENTS HAD BEEN COMPLETED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119119 MK-2000 MICROKERATOME MK-2000 HNO NIDEK CO., LTD. MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention