BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 400VS

    MDR report key: 2822676 · Received November 2, 2012

    Report

    Report Number
    2028159-2012-01702
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM. THE COMPANY REP REPLACED THE AIR/FLUID CONTROLLER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND REPLACED AN O-RING ON THE PNEUMATIC CONNECTOR ASSEMBLY. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A TECHNICAL NURSE REPORTED THAT THE EQUIPMENT DISPLAYED SYSTEM MESSAGES DURING A VITREORETINAL PROCEDURE. FOLLOWING A SYSTEM EXCHANGE, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH 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