BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MK-2000

    MDR report key: 7649475 · Received June 29, 2018

    Report

    Report Number
    8030392-2018-00004
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    March 22, 2018
    Report Date
    August 30, 2018
    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 · 0

    NIDEK RECONSIDERED HOW WE MADE DECISION TO REPORT THIS EVENT. INITIALLY, WE STATED AS "NIDEK CO., LTD. DETERMINED THAT IT IS A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR." HOWEVER, INSTEAD, NIDEK CO., LTD. RECONSIDERED IT AND DETERMINED THAT IT WAS A REPORTABLE EVENT AS THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON JUNE 29, 2018.

    Additional Manufacturer Narrative · 1

    [INVESTIGATION] WE NIDEK CONTACTED THE FACILITY THROUGH THE LOCAL DISTRIBUTOR AND GOT THE FOLLOWING INFORMATION; THE HOSPITAL HAS TWO MK-2000 DEVICES(S/N (B)(4)), AND IT WAS NOT ABLE TO IDENTIFY WHICH ONE WAS USED FOR SURGERY. WE OBTAINED AN IMAGE OF THE CORNEAL PROFILE SHOWING THE THICKNESS OF THE FLAP AFTER SURGERY FROM THE FACILITY. THE IMAGE SHOWED THAT THE FLAP THICKNESS IS NOT CONSISTENT BETWEEN 200 AND 400 UM. ALSO, THE CORNEAL THICKNESS WAS ABOUT 400 UM AT THE DEEPEST POINT. THE SURGEON PERFORMED MORE THAN 20 SURGERIES USING THE SAME MK-2000 AFTER THIS EVENT. HOWEVER, NIDEK AND OUR DISTRIBUTOR DID NOT RECEIVE ANY PARTICULAR PROBLEM FROM THIS FACILITY. [LABELING REVIEW] THE OPERATOR MANUAL STATES "IF THE BLADE COVER IS NOT SET PROPERLY, THE INCONSISTENT FLAP THICKNESS MAY OCCUR." [INSPECTION RECORD REVIEW] IT WAS CONFIRMED THAT ALL THE INSPECTION RESULTS MET THE REQUIRED QUALITY CRITERIA AT THE FINAL INSPECTION. BASED ON THE IMAGE OF THE CORNEAL PROFILE, THE BLADE COVER WAS NOT STABLE DUE TO IMPROPER SETTING. OUR OPERATOR MANUAL STATES THE CAUTIONS FOR THE BLADE COVER AND PROCEDURES TO PREVENT LOOSENESS OF BLADE COVER. BASED ON THE ANALYSIS OF THE CORNEA PROFILE AND NO ISSUE FOR MORE THAN 20 PATIENTS AFTER THE EVENT, THIS FACT INDICATES THAT MK-2000 IS OPERATIONAL. THEREFORE IT IS CONSIDERED IMPROPER SETTING POSSIBLY MAY CAUSE TO THIS EVENT. ALTHOUGH THIS EVENT OCCURRED AT THE FACILITY IN (B)(6), THIS DEVICE IS MARKETED IN UNITED STATE. FINALLY, NIDEK CO., LTD. DETERMINED THAT IT IS A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. IF ADDITIONAL SIGNIFICANT INFORMATION IS AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NIDEK RECEIVED A COMPLAINT VIA E-MAIL FROM PATIENT WHO UNDERWENT SURGERY IN (B)(6) ON (B)(6) 2018. THE E-MAIL STATED THAT THE PATIENT UNDERWENT LASIK SURGERY AT A (B)(6) HOSPITAL ON (B)(6) 2018. THE OPERATION FOR THE LEFT EYE WAS SUCCESSFULLY DONE. HOWEVER THE DEVICE STOPPED WHEN THE FLAP WAS CREATED ON THE RIGHT EYE, AND THEN THE OPERATION WAS CANCELED. THE PATIENT REPORTED THAT THE RIGHT EYE HAS 10 DIOPTERS WITH MYOPIA AND ASTIGMATISM. NIDEK RECEIVED INFORMATION FROM THE FACILITY THROUGH THE DISTRIBUTOR THAT THE DEVICE (MK-2000) WAS USED FOR MORE THAN 20 PATIENTS AND NO PROBLEM OCCURRED AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494832 MK-2000 MICROKERATOME MK-2000 HNO NIDEK CO., LTD. MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other