BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEPLUS VALVED ENTRY SYSTEM

    MDR report key: 5369197 · Received January 15, 2016

    Report

    Report Number
    2028159-2016-00224
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Report Date
    February 25, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    NGY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    SAMPLES WERE RECEIVED BY A COMPANY REPRESENTATIVE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. A NON-SAFETY MEDICAL DEVICE CORRECTION WAS COMPLETED ON AUGUST 12, 2015 AND A MANUFACTURING CHANGE IMPLEMENTED TO ADDRESS THE ROOT CAUSE. ALL POTENTIALLY IMPACTED ALCON CUSTOMERS HAVE BEEN CONTACTED, TROCAR PLUGS MADE AVAILABLE, AND OTHER RISK MITIGATIONS DISCUSSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE NURSE. THE TROCARS WERE FROM TWO DIFFERENT PAKS AND STAND ALONE. THE ISSUE OCCURRED AT TWO PATIENTS BUT NO PATIENT HARM REPORTED. THIS REPORT IS FOR THE STAND ALONE TROCARS.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT SOME TROCARS WERE LEAKY. IT IS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT HARM. IT IS UNKNOWN WHICH TROCARS LEAKED AND WHEN THE EVENT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29538 EDGEPLUS VALVED ENTRY SYSTEM CANNULA, TROCAR, OPHTHALMIC NGY ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA 14018474X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other