BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 22503616 · Received July 14, 2025

    Report

    Report Number
    2955842-2025-29761
    Event Type
    Death
    Date Received
    July 14, 2025
    Date of Event
    June 18, 2025
    Report Date
    June 21, 2025
    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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO RELEVANT ERRORS OCCURRED DURING THE PROCEDURE. LOG REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED ON THE SYSTEM SHOW THE SYSTEM FUNCTIONED NORMALLY AND THERE WERE NO INDICATIONS RELATING TO THIS EVENT. THE FOLLOWING CONCOMITANT PRODUCTS WERE USED DURING THE PROCEDURE: ENDOSCOPE PLUS 30 DEGREE, TWO CADIERE FORCEPS, PERMANENT CAUTERY HOOK, VESSEL SEALER EXTEND, SUCTION IRRIGATOR, 8MM 0 DEGREE ENDOSCOPE. A SITE HISTORY REVIEW FOUND NO COMPLAINTS HAVE BEEN RECEIVED FOR THE INSTRUMENTS USED DURING THIS PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT FOUND NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT IN THIS REPORT HAD A BRADYCARDIC EVENT LIKELY FROM A VAGAL RESPONSE DURING A HIATAL HERNIA REPAIR. THIS LED TO ASYSTOLE AND THE PATIENT EXPIRED DESPITE RESUSCITATIVE EFFORTS. NO ALLEGATION IS MADE AGAINST ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPIRED DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT HAD A HISTORY OF LUNG CANCER WITH RADIATION AND CHEMOTHERAPY TREATMENTS RESULTING IN DIFFICULT, SCARRED, AND WEAK TISSUE ANATOMY. WHILE DISSECTING TISSUE NEAR THE VAGUS NERVE, CONTROLLED BLEEDING OCCURRED AND PRESSURE WAS APPLIED. THE PATIENT THEN EXPERIENCED BRADYCARDIA FROM A VASOVAGAL RESPONSE THAT DETERIORATED TO ASYSTOLE. THE BLEEDING SITE WAS PACKED, THE ROBOT WAS EMERGENTLY UNDOCKED, AND THE PROCEDURE WAS CONVERTED TO OPEN. CHEST COMPRESSIONS WERE INITIATED. DESPITE RESUSCITATION EFFORTS THE PATIENT REMAINED IN ASYSTOLE; NO CARDIAC RHYTHM WAS RESTORED AND THE PATIENT EXPIRED. THE SURGEON STATED THAT NO MALFUNCTIONS OF ANY INTUITIVE PRODUCTS OCCURRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771445 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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