BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 6716346 · Received July 14, 2017

    Report

    Report Number
    0002936921-2017-00020
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 14, 2017
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    Z-1245-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY OCCURRED AND NO KNOWN IMPACT OR CONSEQUENCE TO THE DOCTOR 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 ((B)(4)) TO PERFORM THE CORRECTION AS PER Z-1245-2016.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DURING RECALL PROCESS, A NIDEK INCORPORATED RECALL COORDINATOR RECEIVED INFORMATION FROM A CUSTOMER THAT THE NEAR POINT CHART ROD ON THEIR RT-5100S FELL SEVERAL TIMES AND HAD HIT HER AND SEVERAL EMPLOYEES ON THE HEAD ON MULTIPLE OCCASIONS. THE FACILITY HAVE TWO RT-5100 REFRACTORS SERIAL # (B)(4) BUT THE COMPLAINANT CLAIMED THAT SHE DON'T KNOW WHICH DEVICE HIT THE FORMER EMPLOYEE. HOWEVER, THE COMPLAINANT CONFIRMED THAT NO BRUISE OR NO SERIOUS INJURY OCCURRED, AND THEREBY, MEDICAL TREATMENT/ INTERVENTION WAS UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494357 RT-5100 REFRACTOR HKN NIDEK CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR