BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 1760858 · Received July 14, 2010

    Report

    Report Number
    2028159-2010-01178
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A CUSTOMER REPORTED THE SYSTEM FAILED DURING CASE. A SYSTEM MESSAGE WAS REPORTED TO HAVE BEEN RECEIVED. ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO WAS RECEIVED: THE OPERATING ROOM SUPERVISOR REPORTED THIS EVENT HAPPENED DURING A CASE. THE SYSTEM HAD TO BE REBOOTED TWICE TO COMPLETE THE CASE. THE SURGEON MANUALLY INJECTED AIR INTO THE EYE WITH A SYRINGE. THE PT OUTCOME WAS GOOD. ONCE THE CASE WAS COMPLETED, THE SYSTEM WAS EXCHANGED TO COMPLETE THE REST OF THE CASES OF THE DAY. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1