BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 13035565 · Received December 18, 2021

    Report

    Report Number
    2955842-2021-11773
    Event Type
    Death
    Date Received
    December 18, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 19, 2021
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE SURGEON BELIEVES THE CAUSE OF THE REPORTED CARDIAC ARREST AND SUBSEQUENT PATIENT EXPIRATION IS ARRHYTHMIA AND MYOCARDIAL ISCHEMIA FROM AN OCCLUDED CORONARY STENT. HOWEVER, IT IS UNKNOWN IF THE DA VINCI SURGICAL SYSTEM WAS A CONTRIBUTING FACTOR TO THE COMPLICATION. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS COMPLETED. THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, ALL INSTRUMENTS USED DURING THIS PROCEDURE WERE USED IN SUBSEQUENT PROCEDURES EXCEPT FOR THE FOLLOWING: THE TIP-UP FENESTRATED GRASPER WHICH EXPENDED ITS LAST USE DURING THIS PROCEDURE, THE PERMANENT CAUTERY HOOK (PART NUMBER: 470183-14 / LOT NUMBER: N11210308-0076 / 9 USES REMAINING), AND THE LARGE CLIP APPLIER (PART NUMBER: 470230-12 / LOT NUMBER: N10180723-0064 / 88 USES REMAINING). A VESSEL SEALER EXTEND WAS USED DURING THIS PROCEDURE. THIS INSTRUMENT IS A SINGLE-USE INSTRUMENT AND THEREFORE WAS NOT REUSED IN SUBSEQUENT PROCEDURES. NONE OF THE INSTRUMENTS USED DURING THIS PROCEDURE HAVE COMPLAINTS REPORTED AGAINST THEM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY, THE PATIENT EXPERIENCED CARDIAC ARREST AND THEN ULTIMATELY EXPIRED AFTER THE ROBOT WAS UNDOCKED AND ATTEMPTS WERE UNSUCCESSFULLY MADE TO RESUSCITATE THE PATIENT. ALTHOUGH THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT CODING WAS ARRHYTHMIA AND MYOCARDIAL ISCHEMIA FROM AN OCCLUDED CORONARY STENT, IT IS UNKNOWN IF THE DA VINCI SURGICAL SYSTEM WAS A CONTRIBUTING FACTOR. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY, THE PATIENT BEGAN TO EXPERIENCE CARDIAC ARREST. IN AN ATTEMPT TO REVIVE THE PATIENT, THE PATIENT WAS UNDOCKED FROM THE DA VINCI SURGICAL SYSTEM TO PERFORM CARDIOPULMONARY RESUSCITATION (CPR), BUT THE PATIENT ULTIMATELY EXPIRED. THERE WAS NO ALLEGATION OF A MALFUNCTION OR PRODUCT DEFICIENCY. THE ROBOTICS¿ COORDINATOR, WHO INITIALLY REPORTED THE EVENT TO AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE, INDICATED THAT THE EVENT WAS ¿NOT ROBOTIC RELATED.¿ ISI CONTACTED THE OPERATING SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE EVENT: THE SURGEON CONFIRMED THAT THE ENTIRE EVENT TOOK PLACE WITHIN THE OPERATING ROOM (OR) AND THAT THE PATIENT¿S CAUSE OF DEATH WAS A HEART ATTACK. THE SURGEON REPORTED THAT THE CAUSE OF THE PATIENT CODING WAS ARRHYTHMIA AND MYOCARDIAL ISCHEMIA FROM AN OCCLUDED CORONARY STENT. THE SURGEON REPORTED THAT CPR WAS THE ONLY MEDICAL INTERVENTION ADMINISTERED. THE SURGEON REPORTED THAT HE DOES NOT THINK THAT A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY CAUSED OR CONTRIBUTED TO THIS EVENT. THE SURGEON REPORTED THAT AN AUTOPSY HAS BEEN PERFORMED, BUT THAT A COPY IS NOT AVAILABLE FOR ISI¿S REVIEW AT THIS TIME. FINALLY, THE SURGEON NOTED THAT THEIR SITE IS GOING TO PERFORM SIMULATION TRAINING IN THE OR FOR RAPID UNDOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934868 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A 00886874110720

    Patients

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