BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR)

    MDR report key: 7635389 · Received June 25, 2018

    Report

    Report Number
    1222074-2018-00157
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    February 26, 2016
    Report Date
    February 26, 2016
    Manufacturer
    DUTCH OPTHALMIC RESEARCH CENTER BV
    Product Code
    HQC
    UDI-DI
    08717872019659
    PMA / PMN Number
    K142877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS REVIEWED DURING THE RETROSPECTIVE REVIEW. AN ERROR CODE, PHA 103/104, OCCURRED DURING SURGERY, AND HAD TO BE REPLACED, HENCE REPORTABLE. THIS COULD LEAD TO A PROLONGED DELAY. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A VOLUNTARY RETROSPECTIVE REVIEW OF ALL COMPLAINTS SINCE 2015 BY THE MANUFACTURER ((B)(4)). DETAILS OF THIS ACTIVITY WERE DISCUSSED WITH CDRH OFFICE OF COMPLIANCE ((B)(6)) DURING A TELE-CONFERENCE ON (B)(6) 2017. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS COMPLAINT HAS NOW BEEN CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY PHACO WENT LOWER AND LOWER; CHANGED HP NO US POWER. ERROR CODE PHA 103/104.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475221 EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) EVA, COMBINED MACHINE INCLUDING LASER (DORC CONNECTOR) HQC DUTCH OPTHALMIC RESEARCH CENTER BV 8000.COM02 08717872019659

    Patients

    Seq Age Sex Outcome Treatment
    1