BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MK-2000

    MDR report key: 11625556 · Received April 6, 2021

    Report

    Report Number
    8030392-2021-00001
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    April 5, 2021
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HNO
    PMA / PMN Number
    K990900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK KERATOME MODEL:MK-2000 IS A SYSTEM THAT IS USED IN COMBINATION WITH THE HANDPIECE SET AND THE BLADE. THE BLADE IS AN ACCESSORY(CONSUMABLE) THAT INCISES THE CORNEA AND CREATE A FLAP. AFTER RECEIVING THIS INFORMATION, WE INVESTIGATED DHR (DEVICE HISTORY RECORD) OF THE BLADE. WE CONFIRMED THAT THE BLADE MET THE QUALITY CRITERIA AND THE UNDAMAGED ARE SHIPPED. IN ADDITION, THIS WAS THE ONLY EVENT IN THE SAME LOT, AND NO TREND WAS OBSERVED. IN THE SURGERY AFTER THE BLADE REPLACEMENT, WE CONFIRMED THAT THE SYMPTOMS WAS IMPROVED AND THE DEVICE WAS FOUND TO BE IN WORKING ORDER. THE OPERATOR'S MANUAL PROVIDES PRECAUTIONS FOR HANDLING THE BLADE EDGE DURING THE SYSTEM SETTING AND A FLAP CREATION, AND IT ALSO DESCRIBES INCOMPLETE CORNEAL FLAPS AS AN ADVERSE EVENT. THE OCCURRENCE OF ADVERSE EVENT CAN BE PREVENTED BY FOLLOWING THE OPERATOR'S MANUAL. NIDEK CO. LTD. CONSIDERS THIS CASE A REPORTABLE EVENT AS IT HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE SURGERY IS PERFORMED WITHOUT FOLLOWING WITH THE STEP IN THE OPERATOR'S MANUAL.

    Description of Event or Problem · 1

    NIDEK'S DISTRIBUTOR IN (B)(6) REPORTED THAT UNEVEN CUT THICKNESS AND "GROOVE" ALONG THE EDGE OF THE FLAP WERE FOUND AFTER FLAP FORMATION WITH NIDEK KERATOME MODEL:MK-2000 (S/N.(B)(4)). AFTER REPLACING WITH ANOTHER NEW BLADE, ANY PROBLEM DID NOT RECUR. THE DAMAGE ON THE EDGE OF THE BLADE WAS FOUND OBSERVING THE SUBJECT BLADE UNDER THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514601 MK-2000 MICROKERATOME MK-2000 HNO NIDEK CO., LTD. MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention