BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION SILVER SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE

    MDR report key: 9090233 · Received September 19, 2019

    Report

    Report Number
    2028159-2019-01719
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    June 15, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED: THE PHACO HANDPIECE WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE FOUND A NO NONCONFORMITIES. A FLOW RATE TEST WAS PERFORMED ON THE IRRIGATION AND ASPIRATION LINES OF THE HANDPIECE, WHICH FOUND THE HANDPIECE TO MEET PRODUCT SPECIFICATIONS. THE RETURNED PHACO HANDPIECE WAS CONNECTED TO A CALIBRATED SYSTEM. THE PHACO HANDPIECE TUNED SUCCESSFULLY AND COMPLETED A FIVE-MINUTE BURN-IN TEST WITH THE SYSTEM SET AT 100% ULTRASONIC AND TORSIONAL POWER. THE TEMPERATURE OF THE PHACO HANDPIECE SHELL WAS MEASURES PER PS 980-2150-012 AND WAS FOUND TO MEET SPECIFICATIONS. THE PHACO HANDPIECE WAS CONNECTED TO DYNAMIC TUNING FIXTURE (DTF) FOR STROKE LENGTH TESTING ON THE LONGITUDINAL AND TORSIONAL MOVEMENTS, WHICH FOUND THE STROKE LENGTH AND DID NOT MEET PRODUCT SPECIFICATIONS. NO FUNCTIONAL PROBLEM WAS FOUND WITH THE RETURNED PHACO HANDPIECE, AS RELATED TO THE REPORTED EVENT. THEREFORE, THE CUSTOMER REPORTED EVENT COULD NOT BE CONFIRMED. UNRELATED TO THE REPORTED EVENT, TESTING FOUND NONCONFORMING ELECTRODES, WHICH CAUSED THE TORSIONAL STROKE LENGTH NOT MEETING PRODUCT SPECIFICATIONS. HOWEVER, HOW OR WHEN THE ELECTRODE BECAME NONCONFORMING REMAINS INCONCLUSIVE. THE PHACO HANDPIECE MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVALUATION IS IN PROGRESS. 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).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PHACOEMULSIFICATION HANDPIECE BECOMES HOT BEFORE SURGERY DURING TUNING AND DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889976 CENTURION SILVER SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1