BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 3851669 · Received April 18, 2014

    Report

    Report Number
    2028159-2014-00696
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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

    NURSE REPORTED THAT THE ASPIRATION/INFUSION FUNCTION DID NOT WORK DURING A CATARACT SURGERY. SYSTEM WAS EXCHANGED AND SURGERY WAS COMPLETED WITH NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238492 ACCURUS 800CS PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS ANTERIOR MULTI PAK