BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1894948 · Received November 5, 2010

    Report

    Report Number
    2028159-2010-02178
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 8, 2010
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH (B)(4) WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: (B)(6) 2010. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THE VITREOTOME GOT STUCK IN THE TROCAR CANNULA DURING SURGERY. THE SURGEON OPENED A NEW PAK AND REPLACED THE VITREOTOME AND THE TROCAR. THE PROCEDURE LASTED 30 TO 40 MINUTES LONGER THAN USUAL. A RETINAL TEAR OCCURRED AT THE BACK OF THE TROCAR ENTRY DOOR LEADING TO A PREOPERATIVE RETINAL DETACHMENT. A GAS TAMPONADE WAS PUT IN PLACE. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 Required Intervention