BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 1823666 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01600
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    July 29, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE MEMORY WAS PROGRAMMED INCORRECTLY. THE MEMORY WAS RESET CORRECTLY. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "FOOTSWITCH WOULD ONLY ALLOW FUNCTIONS TO MOVE FORWARD" (DEVICE OPERATES DIFFERENTLY THAN EXPECTED). THE PATIENT CARE DIRECTOR REPORTED THAT DURING SURGERY, THE SURGEON WAS USING THE FOOTSWITCH TO NAVIGATE BACK TO A FUNCTION. THE FOOTSWITCH WOULD ONLY ALLOW FUNCTIONS TO MOVE FORWARD. THE CIRCULATING NURSE USED THE TOUCHSCREEN TO NAVIGATE. THE CASE WAS COMPLETED AS PLANNED WITH A 5-10 MINUTE DELAY. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK