BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 4357961 · Received December 16, 2014

    Report

    Report Number
    3002807715-2014-00044
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    November 25, 2014
    Report Date
    November 26, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. ON EVALUATION NIDEK SE FOUND THE NEAR POINT CHART ARM HINGE WAS NOT PROPERLY BOLT TO THE HOLDER ASSEMBLY, WHICH CAUSED THE FREE FALL OF NEAR POINT CHART ARM. SE REPLACED THE COMPLETE SET OF HOLDER ASSEMBLY. THE SYSTEM WAS TESTED FOR PROPER OPERATION AND HAS BEEN FUNCTIONAL. NIDEK CLINICAL SPECIALIST CONTACTED THE TECHNICIAN AND VERIFIED ABOUT THE COMPLAINT. TECHNICIAN REPORTED THAT ON (B)(6) 2014 SHE GOT CORNEAL INJURY DUE TO THE NEAR POINT CHART ARM OF RT-5100 WHICH FELL DOWN AND HIT HER CORNEA. ON EXAMINATION BY SLIT LAMP AND FLUORESCEIN STAINING DOCTOR NOTICED A CORNEAL ABRASION. THE ABRASION WAS TREATED BY BANDAGE CONTACT LENS FOR OVERNIGHT FOLLOWED BY TEAR DROPS (AS NEEDED) FOR THE NEXT DAY. THE TECHNICIAN FELT BETTER AFTER TWO DAYS. NIDEK INC CONSIDERS IT A REPORTABLE EVENT AS THE DEVICE HAS MALFUNCTIONED AND HAD RESULTED AN INJURY.

    Description of Event or Problem · 1

    NIDEK RECEIVED A COMPLAINT FROM THE CUSTOMER ON (B)(6) 2014. CUSTOMER REPORTED ABOUT AN INJURY TO THE TECHNICIAN WHILE USING RT-5100, SN: (B)(4). CUSTOMER REPORTED THAT THE NEAR POINT CHART ARM FELL DOWN AND SCRATCHED THE CORNEA OF ONE OF THE TECHNICIANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826299 RT-5100 REFRACTOR HKN NIDEK CO., LTD. RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK