BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 3042901 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00383
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 14, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SVC REPORT INDICATES THE SYS HAD NO DISPLAY AFTER HEARING A WHISTLING SOUND. THE CUSTOMER CALLED THE COMPANY REP TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REP REVIEWED WITH THE CUSTOMER ABOUT THE PROPER POWER UP SEQUENCE AND THE CONSEQUENCES OF PRESSING THE FRONT POWER BUTTON MORE THAN ONCE DURING THE BOOT UP SEQUENCE. THE FACILITY DID NOT REQUEST SVC. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL 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 INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. WHILE IT IS NOT ENTIRELY CONCLUSIVE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS USER MISUSE, AS THE CUSTOMER WAS INFORMED ABOUT THE PROPER USE OF THE EQUIPMENT. (B)(4).

    Description of Event or Problem · 1

    A MANAGER REPORTED THERE WAS NO DISPLAY AFTER HEARING WHISTLING SOUND FROM THE EQUIPMENT DURING A VITRECTOMY PROCEDURE. FOLLOWING A SYSTEM EXCHANGE, THE PROCEDURE WAS COMPLETED WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94782 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1