BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 960288 · Received April 30, 2007

    Report

    Report Number
    1644019-2007-00012
    Event Type
    Malfunction
    Date Received
    April 30, 2007
    Date of Event
    March 28, 2007
    Report Date
    March 28, 2007
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 25 GAUGE CUTTER COULD NOT BE PULLED OUT FROM THE 25 GAUGE TROCAR AFTER THE VITRECTOMY WAS FINISHED. THE DOCTOR HAD NO CHOICE BUT TO PULL OUT THE CUTTER AND TROCAR TOGETHER. THE DOCTOR THOUGHT IT WAS A DANGEROUS SITUATION, AND A NONCONFORMING TROCAR WAS TO BLAME. THE DOCTOR CONFIRMED THERE WAS NO HEALTH IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS OPHTHALMIC SURGERY SYSTEM HQE ALCON - HOUSTON ACCURUS 800CS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA