BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2211643 · Received August 5, 2011

    Report

    Report Number
    2028159-2011-00912
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 6, 2011
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED EVENT. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE BATTERY, FAN GUARD, PNEUMATIC CONNECTORS AND LATCH SEAL WERE REPLACED AS PART OF THE PM. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. NO SAMPLES WERE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE SYS DID NOT PERFORM THE SILICONE OIL "FLUIDICS/GAS" INFUSION DURING A VITRECTOMY PROCEDURE. A MANUAL TECHNIQUE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF LESS THAN 15 MINUTES AND THERE WAS NO HARM TO THE PT.

    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