BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2193480 · Received July 13, 2011

    Report

    Report Number
    2028159-2011-00805
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Report Date
    March 16, 2011
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT EVAL PERFORMED ON THE RETURNED SAMPLE (23GA ACCURUS) RESULTED IN THE FOLLOWING FINDINGS: A VISUAL INSPECTION DEEMED THE SAMPLE WAS CONFORMING. THE SAMPLE WOULD ACTUATE PROPERLY, BUT WOULD NOT CUT PROPERLY (STRANDS). THE PROBE ASPIRATED ACCORDINGLY. THE DEVICE HISTORY RECORDS FOR THE COMPONENT LOTS WERE REVIEWED. THE ASSOCIATED LOTS (9) WERE RELEASED BASED ON COMPANY'S ACCEPTANCE CRITERIA. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. THE INNER CUTTER EXHIBITED SIGNIFICANT WEAR ON THE CUTTING EDGE (RESHAPED) INDICATING THE PROBE MAY HAVE BEEN USED EXTENSIVELY. THE SIGNIFICANTLY WORN/DAMAGED INNER CUTTER EDGE HAS AFFECTED THE CUTTING ABILITY OF THE PROBE. IT MUST ALSO BE NOTED THAT MACHINE VIT VALVES NEEDED TO BE REPAIRED WHEN IT WAS EVALUATED BY FIELD SERVICE PERSONNEL. THE PRODUCT EVAL DETERMINED A DAMAGED CUTTING EDGE. SIGNIFICANT WEAR AND NICK ON THE CUTTING EDGE INDICATES THAT THE PROBE MAY HAVE BEEN INITIALLY WORKING PROPERLY AND ONLY DAMAGED SOMETIME DURING SURGERY. SIGNIFICANT USE OF THE PROBE WAS EVIDENT. FURTHERMORE, THE MACHINE'S VIT VALVES NEEDED TO BE REPAIRED WHEN IT WAS EVALUATED BY FIELD SERVICE PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE VITRECTOMY PROBES WERE NOT CUTTING AND THE ASPIRATION WOULD NOT FUNCTION. THE CUSTOMER INDICATED ALL THE PROBES ARE TESTED TWICE PRIOR TO USE; ONCE BY THE SCRUB TECH, AND ONCE BY THE SURGEON BEFORE ENTERING THE PT'S EYE. THERE HAVE BEEN NO PTS HARMED BY THESE PROBES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PACK, 23 GAUGE