BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16928363 · Received May 14, 2023

    Report

    Report Number
    2955842-2023-13628
    Event Type
    Death
    Date Received
    May 14, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 19, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED FROM THE SURGEON, THE PATIENT'S DEATH WAS UNRELATED TO A DA VINCI PRODUCT. THERE WERE NO ISSUES DURING THE ROBOTIC PROCEDURE, THEREFORE, NO PRODUCT WAS RETURNED FOR EVALUATION. A SYSTEM LOG REVIEW DETERMINED THAT THERE WERE NO SIGNIFICANT ISSUES OR ERRORS THAT OCCURRED DURING THE PROCEDURE. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES WERE IDENTIFIED. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, THIS PATIENT SUFFERED FROM A POSTOPERATIVE PULMONARY EMBOLISM SHORTLY AFTER A ROBOTIC HYSTERECTOMY. PULMONARY EMBOLISM IS AN UNFORTUNATE BUT COMMON POSTOPERATIVE EVENT THAT CAN HAVE CATASTROPHIC CONSEQUENCES. THE MANNER AND MECHANISM OF HOW IT OCCURRED IN THIS INSTANCE IS UNKNOWN. THEREFORE, THERE IS INSUFFICIENT EVIDENCE TO ASCERTAIN IF ANY ISI PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNEVENTFUL DA VINCI ASSISTED HYSTERECTOMY DUE TO MALIGNANCY, HOWEVER, CODED AND EXPIRED APPROXIMATELY 45-60 MINUTES LATER WHILE IN THE POST-ANESTHESIA CARE UNIT. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS PRESENT DURING THE SURGICAL PROCEDURE AND CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY AND THAT THERE WERE NO DA VINCI PRODUCT ISSUES. THE CSR SPOKE WITH THE SURGEON WHO STATED THAT THE SUSPECTED CAUSE OF DEATH WAS DUE TO A PULMONARY EMBOLISM. AN AUTOPSY REPORT WAS NOT YET AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662231 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES