BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 7072065 · Received November 30, 2017

    Report

    Report Number
    0002936921-2017-00025
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 11, 2017
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER (B)(4) PROVIDED ON THE INITIAL MDR SUBMITTED WAS FOR THE TABLE, THE RT-5100 IN QUESTION CORRECT SERIAL NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY OCCURRED AND NO KNOWN IMPACT OR CONSEQUENCE TO THE EMPLOYEE (USER'S FACILITY TECHNICIAN) THAT WAS INVOLVED. HOWEVER, NIDEK INCORPORATED CONSIDERS THIS ISSUE A REPORTABLE EVENT AS THE DEVICE HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NIDEK INC. IS AWARE OF THIS ISSUE AND CORRECTIVE ACTION HAS BEEN IMPLEMENTED UNDER RECALL Z-1245-2016. NIDEK HIRED A THIRD PARTY (NORITSU) TO PERFORM THE CORRECTION AS PER Z-1245-2016 AND HAS COMPLETED THE REPAIR SERVICE ON 11/16/2017.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL MDR SUBMITTED ON 11/30/2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A NIDEK INC. CUSTOMER SERVICE RECEIVED AN E-MAIL INFORMATION FROM A CUSTOMER THAT THE NEAR POINT ROD FROM RT-5100 SERIAL #(B)(4) HAD HIT HER ON THE HEAD DURING SET-UP. CUSTOMER STATED SHE DID NOT HAVE ANY OPEN WOUND, BRUISE, OR BUMP AND DID NOT SEEK ANY MEDICAL TREATMENT. SHE WAS THE ONLY TECHNICIAN INVOLVED IN THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851298 RT-5100 REFRACTOR HKN NIDEK CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR