BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURUS 800CS

    MDR report key: 2163441 · Received July 8, 2011

    Report

    Report Number
    2028159-2011-00799
    Event Type
    Other
    Date Received
    July 8, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HOSP RISK MANAGER REPORTED THAT A 25 GAUGE TROCAR CANNULA WAS USED DURING A VITRECTOMY PROCEDURE. THE TROCAR WAS REMOVED AND AT THAT TIME, IT WAS NOTED THAT THE TROCAR WAS BROKEN AND PART OF IT WAS RETAINED WITHIN THE VITREOUS SPACE. ADD'L INFO HAS BEEN REQUESTED MULTIPLE TIMES, BUT NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other