BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL

    MDR report key: 10729543 · Received October 23, 2020

    Report

    Report Number
    3006695864-2020-00474
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474596122
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4: THE CORRECT MANUFACTURING DATE IS 10/17/2017 AS PROVIDED IN THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TROUBLE-SHOOTING WITH TECHNICAL SUPPORT (TS) WAS PERFORMED AND OPERATION OF THE FOOT PEDAL WAS TESTED REMOTELY WITH THE SYSTEM TEST PROCESS. TS VERIFIED THAT BLUETOOTH COMMUNICATION AND CONNECTIVITY BETWEEN FOOTPEDAL AND CONSOLE WAS WORKING PROPERLY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE. THE FSE RECONNECTED THE FOOTPEDAL AND CONFIRMED THAT IT PASSED FULL FUNCTION AND CALIBRATION TESTS. BATTERY WAS CHARGED AT 100 PERCENT. A REVIEW OF RECORDS RELATED TO THE WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF ANY FURTHER RELEVANT INFORMATION IS 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

    LOST COMMUNICATION BETWEEN THE FOOTPEDAL AND PHACO SYSTEM RESULTING IN AN UNPLANNED VITRECTOMY WAS REPORTED. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THAT DURING CATARACT REMOVAL SURGERY ON (B)(6) 2020, THE FOOTPEDAL AND PHACO MACHINE LOST COMMUNICATION DURING A DENSE CATARACT PROCEDURE OF A MALE PATIENT¿S RIGHT EYE (OD). VITRECTOMY WAS REQUIRED. THE CATARACT SURGERY WAS COMPLETED USING THE SAME PHACO CONSOLE. THIS REPORT IS FOR THE WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL. A SEPARATE REPORT WILL BE SUBMITTED FOR THE WHITESTAR SIGNATURE PRO ADV LINEAR CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190393 WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL HQC JOHNSON & JOHNSON SURGICAL VISION, INC. NGP680703 05050474596122

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention