BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO CONSOLE

    MDR report key: 9875160 · Received March 24, 2020

    Report

    Report Number
    3006695864-2020-00195
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    March 2, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474596146
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT OR THE OPERATION OF THE FOOT PEDAL ACCESSORY. ALTHOUGH THE FIELD SERVICE NOTED NO ISSUES FOUND, HE NOTED THE SOUND NOTIFICATION FOR THE IRRIGATION ENABLED WAS AT THE OFF POSITION AND ADVISED THE STAFF AND SURGEON. THE SURGERY CENTER TOOK THE RECOMMENDATIONS OF THE ENABLING THE NOISE NOTIFICATION AND TURNED ON THE FEATURE FOR NOTIFICATIONS. AN ANNUAL PREVENTATIVE MAINTENANCE WAS PERFORMED. A FIELD SERVICE CHECKLIST WAS PERFORMED. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    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

    H4: ADDITIONAL: IN INITIAL REPORT, THE MANUFACTURER YEAR WAS ONLY PROVIDED, HOWEVER THE FULL DATE IS 01/18/2016. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    MANUFACTURER YEAR 2016 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

    DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY CENTER REPORTED A CAPSULAR TEAR IN THE PATIENT¿S OPERATIVE EYE REQUIRING AN INCISION ENLARGEMENT AND A VITRECTOMY PROCEDURE WHEN USING THE WHITESTAR SIGNATURE PRO CONSOLE. A DESCRIPTION OF THE EVENT INDICATED DURING THE PROCEDURE; WHEN THE SURGEON PRESSED THE FOOT PEDAL, THE CONTINUOUS IRRIGATION HAD STOPPED. SINCE THE IRRIGATION FEATURE WOULD NOT WORK WHEN THE FOOT PEDAL WAS PRESSED, THE USER RESORTED BY USING THE BUTTON ON THE MONITOR SCREEN TO ENABLE THE IRRIGATION FEATURE. WHEN THE IRRIGATION FEATURE WAS TURNED ON, IT CAME AT A HIGH PRESSURE CAUSING THE CAPSULE TO TEAR. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336998 WHITESTAR SIGNATURE PRO CONSOLE PHACOFRAGMENTATION UNIT HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680301 05050474596146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOOTPEDAL.