BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002807715-2016-00017

    MDR report key: 5626380 · Received May 3, 2016

    Report

    Report Number
    3002807715-2016-00017
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 4, 2016
    Report Date
    April 4, 2016
    Removal / Correction Number
    2936921-02/12/2016-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK HAD ALREADY REPORTED TO FDA SIMILAR ADVERSE EVENT AND TAKEN REMEDIAL ACTION IN 2014 (Z-1853-2014). NIDEK ALSO HAS BEGUN ADDITIONAL FIELD CORRECTION (Z-1245-2016) ON 3/24/2016 SINCE NIDEK RECEIVED SIMILAR CUSTOMER COMPLAINTS. BASED ON OUR DATABASE, NIDEK WAS ABLE TO CONFIRM THIS RT-5100(SERIAL NUMBER (B)(4)) IS WITHIN THE SCOPE OF THE ONGOING RECALL (Z-1245-2016). THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, NIDEK HIRED THIRD PARTY (B)(4) VISITED THE CUSTOMER SITE FOR ON-SITE EVALUATION AND PERFORMED THE CORRECTION AS PER THE RECALL. NIDEK CONFIRMED THAT THE INJURY WAS MINOR AND DID NOT NEED ANY SURGICAL OR MEDICAL INTERVENTION. NIDEK CONSIDERS IT 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.

    Description of Event or Problem · 1

    NIDEK INC. RECEIVED A COMPLAINT FROM A DISTRIBUTOR ON (B)(6) 2016. CUSTOMER CALLED OUR US DISTRIBUTOR AND REPORTED THAT THE NEAR POINT CHART ARM FOR RT-5100 SN. (B)(4) KEPT FALLING DOWN AND HAVE HIT THE TECHNICIANS ONCE AND THE DOCTOR TWICE IN THE HEAD. CUSTOMER REPORTED ABOUT THE SMALL BRUISE THAT TIME.

    Patients

    Seq Age Sex Outcome Treatment
    1