BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT INTUITIV CONSOLE

    MDR report key: 8352033 · Received February 19, 2019

    Report

    Report Number
    3006695864-2019-00136
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 23, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474573628
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    ADDITIONAL: IN INITIAL REPORT, THE MANUFACTURER YEAR AND MONTH WAS ONLY PROVIDED, HOWEVER THE FULL DATE IS 04/16/2015. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER MONTH AND YEAR APRIL 2015. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE WAS ABLE TO CONFIRM THE VITRECTOMY ERROR WHEN ATTEMPTING TO DUPLICATE IT. THE FIELD SERVICE ENGINEER REPLACED THE VITRECTOMY VALVE AND SENSOR MANIFOLD. A FIELD SERVICE CHECKLIST WAS PERFORMED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A SURGERY CENTER REPORTED AN UNPLANNED VITRECTOMY AND ABORTED PROCEDURE WITH THE COMPACT INTUITIV CONSOLE. A DESCRIPTION FROM THE SURGERY CENTER INDICATED DURING AN UNPLANNED VITRECTOMY PROCEDURE, A 340-ERROR-PNEUMATIC VITRECTOMY PRIME FAILURE DISPLAYED DURING THE PRIMING OF THE VITRECTOMY CUTTER. THE SURGERY CENTER WAS NOT ABLE TO COMPLETE PROCEDURE. ALTHOUGH, ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, THE SURGERY CENTER WAS NOT WILLING TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143889 COMPACT INTUITIV CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. SCP680300 05050474573628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention