BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 19698271 · Received July 8, 2024

    Report

    Report Number
    2955842-2024-16735
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE SYSTEM LOGS FOUND NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM ALSO FOUND NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE DEVICE(S) USED DURING THE PROCEDURE AND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS EVENT. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THIS PROCEDURE: 30 DEGREE ENDOSCOPE PLUS, FENESTRATED BIPOLAR FORCEPS, TIP-UP FENESTRATED GRASPER, MONOPOLAR CURVED SCISSORS, 2 MEDIUM-LARGE CLIP APPLIERS. A SITE HISTORY REVIEW SHOWS NO COMPLAINTS HAVE BEEN REPORTED FOR ANY OF THESE PRODUCTS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THE PATIENT UNDERWENT AN UNEVENTFUL LOW ANTERIOR RESECTION. HOWEVER, THEY DEVELOPED A PULMONARY EMBOLISM ON POST-OPERATIVE DAY 1 AND EXPIRED BECAUSE OF THE EVENT. THE DIAGNOSIS WAS CONFIRMED BY A COMPUTED TOMOGRAPHY SCAN AND AN AUTOPSY. NO ALLEGATION HAS BEEN MADE REGARDING INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS. PULMONARY EMBOLISM IS A KNOWN POTENTIAL POST-OPERATIVE COMPLICATION AND CAN OCCUR REGARDLESS TO THE TYPE OF SURGERY OR THE MANNER IN HOW IT IS PERFORMED. NO INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER AN UNEVENTFUL DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC ARREST THE FOLLOWING DAY AND EXPIRED. THE SURGEON STATED THAT THERE WERE NO COMPLICATIONS DURING THE SURGERY. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THE PATIENT WAS TRANSFERRED TO THE WARD FOR RECOVERY. THE FOLLOWING DAY, THE NURSES FOUND THE PATIENT IN CARDIAC ARREST AND ATTEMPTED CHEST COMPRESSIONS. RESUSCITATION WAS NOT SUCCESSFUL. A CT SCAN AND AN AUTOPSY DETERMINED THAT THE PATIENT HAD SUFFERED A PULMONARY ARTERY EMBOLISM WITH ALVEOLAR OBSTRUCTION BY THE BLOOD CLOT. THE SURGEON STATED THAT THIS EVENT WAS NOT RELATED TO THE USE OF A DA VINCI SYSTEM, OR A MALFUNCTION OF AN INSTRUMENT, OR ACCESSORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498795 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-46 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death DA VINCI INSTRUMENTS AND ACCESSORIES