BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 3042894 · Received March 5, 2013

    Report

    Report Number
    2028159-2013-00331
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 6, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS. THE PRESSURE VACUUM MANIFOLD WAS REPLACED PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THREW 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 (B)(4) DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED A SYS MESSAGE AND LOCKED DURING A VITRECTOMY PROCEDURE. THE PROCEDURE WAS CANCELED AFTER THE PT REC'D RETROBULBAR ANESTHESIA. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94756 ACCURUS 400VS PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1