BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS SURGICAL SYSTEM

    MDR report key: 6147778 · Received December 6, 2016

    Report

    Report Number
    2028159-2016-05571
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 25, 2016
    Report Date
    February 28, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    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?., EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. ONE 25GA+ COMPANY PROBE SAMPLE WAS RETURNED FOR EVALUATION FOR THE REPORT OF A CUTTING FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS TRACEABLE TO THE REPORTED LOT NUMBER HAS BEEN PERFORMED. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A COMPLAINT HISTORY EXAMINATION INDICATES THERE WERE NO ADDITIONAL COMPLAINTS FOR THE REPORTED ISSUE. THE SAMPLE WAS VISUALLY INSPECTED AND WAS DEEMED CONFORMING. ACTUATION TESTING WAS PERFORMED AND WAS DEEMED INITIALLY NONCONFORMING. THE CUTTER DID NOT FULLY CLOSE IN THE PORT. ASPIRATION TESTING WAS PERFORMED AND WAS DEEMED NONCONFORMING, DUE TO THE ASPIRATION BEING TOO SLOW. CUT TESTING WAS PERFORMED AND WAD DEEMED CONFORMING. THE PROBE WAS DISASSEMBLED AND THE COMPONENTS INSPECTED. THERE WAS APPROXIMATELY 5 MINUTES OF WEAR ON THE INNER CUTTER WHEN COMPARED TO THE CUTTER WEAR VISUAL STANDARDS. THERE WAS SLIGHT RESISTANCE FELT WHEN REMOVING THE INNER CUTTER FROM THE NEEDLE. SLIGHT WEAR MARKS WERE PRESENT AT THE BEND AREA. THE O-RINGS, SPACERS, DIAPHRAGM AND SPRING WERE ALL INTACT. THE COMPLAINT EVALUATION DOES NOT CONFIRM THE PROBE WOULD NOT CUT. THE PROBE CUT TO SPECIFICATION. THE COMPLAINT EVALUATION DOES INDICATE THE PROBE SAMPLE HAD UNRELATED COMPLAINT ISSUES FOR ACTUATION AND ASPIRATION. THE EXACT ROOT CAUSE FOR THE ACTUATION AND ASPIRATION FAILURES CANNOT BE DETERMINED. THE NONCONFORMANCES APPEAR TO BE FROM SOME FORM OF BLOCKAGE WITHIN THE NEEDLE. THIS BLOCKAGE WOULD NOT ALLOW THE CUTTER TO FULLY CLOSE AND MAY IMPEDE THE MOVEMENT OF THE CUTTER SHAFT, CAUSING POOR ACTUATION AND ASPIRATION. A WORN INNER CUTTING EDGE FROM DAMAGE OR AN INCORRECT CUTTER BEND ANGLE WILL ALSO PREVENT CUTTER MOVEMENT AND MAY RESULT IN SLOWER ASPIRATION RATE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED THAT A VITREOUS CUTTER WOULD NOT CUT DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797517 ACCURUS SURGICAL SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER 800CS NA

    Patients

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