BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-1500

    MDR report key: 4304381 · Received December 1, 2014

    Report

    Report Number
    3002807715-2014-00037
    Event Type
    Malfunction
    Date Received
    December 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    November 5, 2014
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    Z-1853-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED TO NIDEK FOR EVALUATION. HOWEVER, A NIDEK SERVICE ENGINEER (SE) HAD CONDUCTED AN ON-SITE EVALUATION. THE DEVICE WAS EVALUATED. SE FOUND THE HINGE (P/NO. 82001CB033) HAD DEGRADED FAILURE. THE PART WAS REPLACED AND THE PREVENTIVE MAINTENANCE WAS DONE ACCORDING TO THE RECALL PROCEDURE. THE NEAR POINT CHART ARM HAS BEEN FIXED. NIDEK CONTACTED THE CUSTOMER TO VERIFY THE COMPLAINT ABOUT THE CUT ON THE NOSE AND CONFIRMED THAT THE INJURY WAS MINOR. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED FOR THE INJURY. NIDEK INC. 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 RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2014. DURING THE USE OF RT-5100; SN (B)(4), THE NEAR POINT CHART ARM FELL DOWN AND HIT THE DOCTOR ON HIS NOSE. DOCTOR GOT CUT ON HIS NOSE. DOCTOR ALSO REPORTED THAT THIS INCIDENT HAPPENED AFTER THE PREVENTIVE MAINTENANCE WAS DONE FOR THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774834 RT-1500 REFRACTOR HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK