BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1834421 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01729
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CALLED IN TO TECHNICAL SERVICES AND ORDERED A NEW FOOT PEDAL. THE REPLACED FOOT PEDAL HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "FOOTSWITCH CRUSHED CABLE AND EXPOSED WIRES" (DEVICE DAMAGED PRIOR TO USE). A CUSTOMER REPORTED THE FOOTSWITCH WAS NOT WORKING CORRECTLY. ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO WAS RECEIVED: A NURSE REPORTED THE FOOTPEDAL CORD HAD BEEN CRUSHED BY EQUIPMENT ROLLING OVER IT AND THE WIRES EXPOSED. THE CASE WAS COMPLETED USING THE FOOTPEDAL, BUT THE SURGEON WAS UNABLE TO USE IT FOR COAGULATION. A SECOND SYSTEM WAS USED FOR COAGULATION PURPOSES ONLY. THERE WAS NO PT HARM 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