BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TEN THOUSAND OCUTOME

    MDR report key: 419926 · Received September 25, 2002

    Report

    Report Number
    2028159-2002-00263
    Event Type
    Malfunction
    Date Received
    September 25, 2002
    Date of Event
    August 26, 2002
    Report Date
    August 26, 2002
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED LOW VACUUM DURING VITRECTOMY AT BEGINNING OF SURGERY. CHANGED CASSETTE AND PROBE WITH NO IMPROVEMENT. CLOSED EYE; ABORTED CASE. FOLLOW-UP NOTED PATIENT BROUGHT BACK IN 09/2002; FOUND THEY HAD PROBLEMS AGAIN. INCREASED VACUUM AND COMPLETED CASE AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND OCUTOME VITREORETINAL SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR