BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK-2000

    MDR report key: 4213149 · Received September 25, 2014

    Report

    Report Number
    3002807715-2014-00021
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    January 1, 2013
    Report Date
    October 3, 2013
    Manufacturer
    NIDEK CO., LTD. HAMACHO PLANT
    Product Code
    HNO
    PMA / PMN Number
    K990900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED TO NIDEK FOR EVALUATION ON 10/03/2013. NIDEK SERVICE ENGINEER (SE) HAD CONDUCTED AN EVALUATION AND THE UNIT WAS TESTED FOR PROPER OPERATION. ON EVALUATION NO FAILURE WAS FOUND. THE UNIT WAS WITHIN THE SPECIFICATIONS. THE UNIT HAS BEEN OPERATIONAL. NIDEK NOTICED THAT THE FACILITY WAS USING A THIRD PARTY'S BLADE DESPITE NIDEK'S STRONG RECOMMENDATION AGAINST ITS USE, AS IT COULD CAUSE SYSTEM MALFUNCTION. THE SE ALSO RECOMMENDED THE CUSTOMER TO USE THE NIDEK'S BLADE FOR SURGERY AND NOT THE THIRD PARTY'S BLAD. REF: NIDEK KERATOME, MODEL MK-2000, OPERATOR'S MANUAL, US EDITION: -2.3 IN USE, 2.3.3 BLAD AND TIP. NIDEK CONTACTED CUSTOMER TO GATHER ADDITIONAL INFO REGARDING THE REPORTED EVENT AND CONFIRMED THAT THERE WAS NO PT INJURY INVOLVED WITH THE EVENT REPORTED; THE PT DID FINE AFTER THE SURGERY. NIDEK CONSIDERS THIS FAILURE MODE 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. (TWO SEPARATE MDR FOR TWO FREE FLAP EVENTS, REF MD - 3002807715-2014-00023).

    Description of Event or Problem · 1

    NIDEK RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2013. DOCTOR REPORTED THAT THEY HAD TWO OCCURRENCE OF FREE FLAPS ON TWO DIFFERENT PATIENTS WITHIN A WEEK WHILE SUING MK-2000 HAND PIECE S/N: (B)(4). DOCTOR REPORTED THEY WERE USING A 130UM BLAD HOLDER WITH A 8.5MM SUCTION RING ON ONE OF THE PATIENTS AND THE SAME 130UM BLAD HOLDER WITH A 9.5MM SUCTION RING ON THE OTHER PT. THERE WAS NO OTHER INFO PROVIDED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599404 MK-2000 HAND PIECE NIDEK KERATOME HNO NIDEK CO., LTD. HAMACHO PLANT MK-2000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK