BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIDEK MK-2000, KERATOME

    MDR report key: 1074456 · Received July 11, 2008

    Report

    Report Number
    2936921-2008-00002
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    November 29, 2007
    Report Date
    July 10, 2008
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    HNO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN LATE 2007 NIDEK INC. WAS ORIGINALLY INFORMED OF THE TWO FREE FLAPS ON TWO DIFFERENT PATIENTS, WE WERE TOLD BY THE FACILITY THAT THERE WAS NO PATIENT INJURY. NIDEK OPENED INCIDENT REPORT. NIDEK RECEIVED THE UNIT IN FOR REPAIR AND FOUND DAMAGE TO THE HANDPIECE THAT MAY HAVE RESULTED IN THE "HINGE" SIZE TOO SMALL, WHICH COULD RESULT IN A FREE FLAP. ALL OTHER FINDINGS/PROBLEMS ON THE MK WERE FROM NORMAL WEAR AND TEAR. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. BASED ON THE SERVICE REPORT AND THE CLAIM THAT NO INJURY OCCURRED, NIDEK CLOSED THIS INCIDENT REPORT. IN EARLY 2008, WE RECEIVED ANOTHER CALL FROM THE SAME FACILITY STATING THEY HAD ANOTHER INCIDENT USING THEIR SECOND MK-2000. THE CALLER DID NOT HAVE ANY DETAILS AT THE TIME. NIDEK OPENED INCIDENT REPORT AND COORDINATED TO HAVE THIS UNIT SENT IN FOR INSPECTION. DUE TO THE FACT THAT NIDEK RECEIVED TWO CALLS WITHIN A SHORT PERIOD OF TIME, CLAIMING SIMILAR ISSUES WITH TWO DIFFERENT KERATOMES, WE DECIDED TO REOPEN THE ORIGINAL INCIDENT REPORT AND STARTED INVESTIGATING. NIDEK MADE REPEATED ATTEMPTS AT CONTACTING THE FACILITY AND WAS TOLD THAT THESE MATTERS WERE BEING HANDLED BY THE RISK MANAGEMENT DEPARTMENT. NIDEK FINALLY RECEIVED ALL THE DOCUMENTATION REGARDING THESE "INCIDENTS" FROM HOSPITAL RISK MANAGEMENT, SIX MONTHS AFTER THE ORIGINAL INCIDENT. AT THIS TIME, WE WERE MADE AWARE THAT ONE OF THE PATIENTS REQUIRED SURGICAL INTERVENTION TO PREVENT IMPAIRMENT TO VISION AND/OR CORNEA. THE PATIENT REQUIRED 4 SUTURES, AFTER THE LASER WAS COMPLETED TO HOLD THE "FREE FLAP" IN PLACE. WE REQUESTED FURTHER PATIENT DATA AND IT WAS RECEIVED ON 07/08/08. THIS INFORMATION STATES THAT THE PATIENT IS HEALING AS EXPECTED WITH NO FURTHER COMPLICATIONS. IN CONCLUSION, NIDEK INC. HAS DETERMINED THIS TO BE USER ERROR THAT CAUSED DAMAGE TO THE MICROKERATOME WHICH RESULTED IN A FREE FLAP.

    Description of Event or Problem · 1

    IN LATE 2007, NIDEK INC RECEIVED A CALL FROM HOSPITAL, REPORTING 2 FREE FLAPS ON TWO PATIENTS WHILE USING THE NIDEK MK-2000, REPORTER STATED THAT NO PATIENT INJURY OCCURRED, HOWEVER, THEY REQUESTED AN INSPECTION AND SERVICE TO BE DONE ON THE KERATOME. NIDEK INC. COMPLETED THE CALL LOG AND INCIDENT REPORT (DOCUMENTING THAT NO PATIENT INJURY OCCURRED) AND ARRANGED TO HAVE THE KERATOME SHIPPED IN FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIDEK MK-2000, KERATOME KERATOME, AC POWERED HNO NIDEK CO. LTD. MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention