BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS

    MDR report key: 3193131 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01226
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE PLUGS WERE BENT AND THE VITRECTOMY CANNULA WOULD NOT FIT IN THE TROCAR. THE PROCEDURE WAS COMPLETED AFTER OPENING ANOTHER PAK. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288530 ACCURUS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 25+ TOTAL PLUS PAK