BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2913461 · Received January 9, 2013

    Report

    Report Number
    2028159-2013-00020
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    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
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND FOUND THE FOOTPEDAL TREADLE DETENTS WERE NOT DETECTED BY THE SYSTEM, HOWEVER ALL OTHER FOOTPEDAL BUTTON PRESSES WERE DETECTED BY THE SYSTEM. THE COMPANY SERVICE REP REPLACED THE FOOTPEDAL TO ADDRESS THE ISSUE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THERE WAS NO SAMPLE 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 ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE EQUIPMENT WAS NOT CUTTING DURING A VITRECTOMY PROCEDURE AND A SYSTEM MESSAGE DISPLAYED AFTER INCREASING THE "AIR SUPPLY". THE CUSTOMER SWITCHED TO AN ALTERNATE UNIT AND FOOTSWITCH TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13018 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS/LEGACY 6 FUNCTION FOOTSWITCH