BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2160903 · Received June 16, 2011

    Report

    Report Number
    2028159-2011-00688
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE PRESSURE REGULATOR. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ADD'L INFO REGARDING PRODUCT EVAL IS PENDING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THE SYSTEM HAD LOW VACUUM ON VFC (VISCOUS FLUID CONTROL) EXTRACTION AND LOW PRESSURE ON INJECTION. NO HARM OR CONSEQUENCE TO THE PT WAS REPORTED. ADD'L INFO REC'D FROM THE BIOMEDICAL TECHNICIAN INDICATED THAT THE ISSUE STEMMED FROM THE FOOTSWITCH. THE FOOTSWITCH HAS BEEN REPLACED AND THE SYSTEM WAS CHECKED AND WAS OPERATING NORMALLY. ADD'L INFO REGARDING THE PT'S STATUS 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 UNK