BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCURUS 800CS

    MDR report key: 2023662 · Received March 3, 2011

    Report

    Report Number
    2028159-2011-00223
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 9, 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
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 THE 25 GAUGE CANNULA BECAME DISINSERTED FROM THE CANNULA HUB UPON REMOVAL OF INFUSION CANNULA. THE METALLIC PORTION OF THE CANNULA REMAINED AFFIXED TO THE INFUSION CANNULA. THE SURGEON INDICATED HE HAD DIFFICULTY MAINTAINING EYE PRESSURE BECAUSE HE HAD ANTICIPATED FILLING THE EYE WITH GAS THROUGH THE CANNULA THAT WAS NO LONGER IN THE EYE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING SINCE THE SURGEON WAS UNABLE TO PUT GAS IN THE EYE THROUGH THE CANNULA AS INTENDED THE GAS WAS INJECTED INTO THE EYE WITH A NEEDLE. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    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 Other