BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS SURGICAL SYSTEM PROCEDURE PAK

    MDR report key: 6025541 · Received October 13, 2016

    Report

    Report Number
    2028159-2016-04635
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    October 4, 2016
    Report Date
    January 4, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    LRO
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN DEVICE AVAILABLE FOR EVALUATION?, DEVICE EVALUATED BY MFR?, DEVICE MANUFACTURE DATE, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. ONE PROBE SAMPLE WAS RETURNED FOR EVALUATION FOR THE REPORT OF THE PROBE NOT ACTUATING. A REVIEW OF THE RELATED DEVICE HISTORY RECORDS ASSOCIATED WITH THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA IN OCTOBER AND NOVEMBER 2015. A COMPLAINT HISTORY EXAMINATION INDICATES THERE WERE NO OTHER COMPLAINTS FOR THE REPORTED ISSUE. THE COMPLAINT SAMPLE WAS VISUALLY INSPECTED AND DEEMED CONFORMING. ACTUATION TESTING WAS PERFORMED AND DEEMED CONFORMING. CUT TESTING WAS PERFORMED AND DEEMED NONCONFORMING. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. THERE IS APPROXIMATELY 15 TO 20 MINUTES OF WEAR ON THE INNER CUTTER WHEN COMPARED TO THE CUTTER WEAR VISUAL STANDARDS. THERE WAS NO RESISTANCE FELT WHEN THE INNER CUTTER WAS REMOVED FROM THE NEEDLE. WEAR MARKS WERE PRESENT AT THE BEND AREA AND THE CUTTING EDGE OF THE INNER CUTTER. THE COMPLAINT EVALUATION DOES NOT CONFIRM THE PROBE HAD AN ACTUATION PROBLEM. THE EVALUATION DOES INDICATE THE CUT PERFORMANCE WAS NONCONFORMING. THE ROOT CAUSE FOR THE PROBE NOT CUTTING CANNOT BE DETERMINED FROM THIS EVALUATION. THE MOSTLY LIKELY CAUSE FOR THE POOR CUTTING IS FROM A WORN INNER CUTTING EDGE FROM DAMAGE OR AN INCORRECT CUTTER BEND ANGLE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED THAT A PROBE PRESENTED WITH NO ACTUATION DURING A SURGERY. THE PROBE WAS EXCHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677565 ACCURUS SURGICAL SYSTEM PROCEDURE PAK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA 15038585X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 25+ TOTAL PLUS PAK