BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 400VS

    MDR report key: 1062473 · Received June 18, 2008

    Report

    Report Number
    2028159-2008-00229
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE LATCH SEAL TUBING CRACKED. THE TUBING AND LATCH SEAL WERE REPLACED. THE COMPLAINT WAS CONFIRMED WHEN A VISUAL INSPECTION OF THE LATCH TUBING REVEALED A CRACK. THE VACUUM CHECK IS PERFORMED THROUGH THIS TUBING WHEN A CASSETTE IS INSERTED, AND A CRACK IN THE TUBING WILL CAUSE A LEAK. SUBSEQUENTLY, THE VACUUM WILL NOT BE HELD, AND THE VACUUM CHECK WILL NOT MEET SPECIFICATIONS. THREE CASSETTES WERE RECEIVED FOR EVALUATION. THE CASSETTES PRIMED SUCCESSFULLY. NO RELATED ISSUES WITH THE REPORTED VACUUM CHECK ISSUE WERE FOUND WITH THE RETURNED CASSETTES. THE ROOT CAUSE OF THE REPORTED ISSUE WAS A CRACK IN THE LATCH TUBING, CAUSING A LEAK THAT PREVENTED THE VACUUM TO HOLD TO MEET SPECIFICATIONS ON THE SYSTEM. A REVIEW OF THE COMPLAINT, SERVICE, AND MANUFACTURING HISTORY DATA FILES FOR THE SYSTEM, INDICATES THERE HAVE BEEN NO ADD'L COMPLAINTS OR SERVICE REQUESTS RELATED TO THE REPORTED EVENT. A TREND REVIEW OF THE COMPLAINT INDICATES THAT THERE HAS BEEN NO RECENT ADVERSE TRENDING OBSERVED IN THE LAST 36 MONTHS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILED VACUUM CHECK. THE CUSTOMER NOTICED A SMALL CUT IN VACUUM LINE GOING TO THE MAIN LATCH. THE PT HAD BEEN BLOCKED AND WAS SEDATED. THE SURGERY HAD NOT BEGUN. THE PT WAS TAKEN TO THE RECOVERY ROOM AND THE CASE WAS RESCHEDULED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS OPHTHALMIC SURGERY SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 400VS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention