BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 12930207 · Received December 3, 2021

    Report

    Report Number
    2955842-2021-11659
    Event Type
    Death
    Date Received
    December 3, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 4, 2021
    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
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THERE ARE NOT ISI PRODUCTS EXPECTED FOR RETURN TO ISI FOR FAILURE ANALYSIS EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF 12-NOV-2021, 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. 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 COMPLAINT. ALL OF THE ERRORS IN THE LOGS FOR THAT PROCEDURE ARE CLASS 8 (ENGINEERING EVENT INFORMATIONAL (NO FAULT REACTION)). NONE OF THESE WOULD SUGGEST A PRODUCT ISSUE. ALL THE INSTRUMENTS USED IN THE CASE HAVE NOT BEEN USED IN SUBSEQUENT PROCEDURES; HOWEVER, SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST ANY OF THE INSTRUMENTS. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: BASED UPON THE INFORMATION IN THE DESCRIPTION OF EVENTS, DURING A DA VINCI ASSISTED NEPHRECTOMY THE AORTA WAS INJURED WHILE THE FIRST ASSISTANT WAS ATTEMPTING TO CLIP A ¿PERIPHERAL¿ VESSEL WITH A LAPAROSCOPIC CLIP APPLIER. THE SURGEON ATTEMPTED TO GAIN CONTROL OF THE BLEEDING AORTA USING THE DA VINCI SYSTEM. THE SURGEON WAS ONLY ABLE TO PARTIALLY OBTAIN CONTROL. A VASCULAR SURGEON WAS CALLED. AFTER A PERIOD OF 30 MINUTES, THE VASCULAR SURGEON ARRIVED IN THE OPERATING ROOM. IT IS STATED ABOVE, THAT BECAUSE THE VASCULAR SURGEON DID NOT HAVE ¿ROBOTIC CREDENTIALS,¿ IT WAS DECIDED THAT THE VASCULAR SURGEON WOULD PROVIDE VERBAL COMMUNICATION TO THE CONSOLE SURGEON TO REPAIR THE AORTA. IT IS UNCLEAR AS TO THE REASONING NOT TO CONVERT THE PROCEDURE TO AN OPEN PROCEDURE ALLOWING THE VASCULAR SURGEON TO PERFORM THE VASCULAR REPAIR. ALTHOUGH THE BLEEDING WAS NOTED TO BE UNDER CONTROL, IT IS UNKNOWN IF THE BLEEDING WAS COMPLETED STOPPED. FURTHERMORE, IT IS UNKNOWN THE VOLUME OF BLOOD LOSS THAT OCCURRED DUE TO THE AORTIC INJURY. IT IS UNCLEAR IF THERE WAS ANY INTERACTION BETWEEN THE ROBOTIC INSTRUMENTATION AND THE LAPAROSCOPIC CLIP APPLIER AT THE TIME OF THE INJURY TO THE AORTA. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED A TEAR TO THE AORTA DURING DISSECTION OF THE RENAL ARTERY AND CLIPPING OF PERIPHERAL VESSELS. ALTHOUGH THE BLEEDING WAS CONTROLLED, THE PATIENT¿S VITALS DROPPED AND THE SURGEON DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE CONVERSION TO OPEN SURGERY AND AFTER THE ROBOT WAS UNDOCKED, THE PATIENT EXPERIENCED CARDIAC ARREST AND EXPIRED. THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS DUE TO MYOCARDIAL INFARCTION SECONDARY TO AN AORTIC INJURY CAUSED BY THE LAPAROSCOPIC HEM-O-LOK INSTRUMENT.

    Description of Event or Problem · 0

    DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, IT WAS REPORTED THAT THE PATIENT'S AORTA TORE DURING THE DISSECTION OF THE RENAL ARTERY AND CLIPPING OF THE PERIPHERAL VESSELS. ACCORDING TO THE INITIAL REPORTER (AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE WHO WAS PRESENT DURING MOST OF THE PROCEDURE), IT WAS UNCLEAR IF THE VESSEL INJURY WAS CAUSED BY A HAND-HELD HEM-O-LOK LAPAROSCOPIC INSTRUMENT USED BY THE FIRST ASSISTANT OR BY A ROBOTIC INSTRUMENT. THE CONSOLE SURGEON REPAIRED THE AORTIC DAMAGE BY PLACING A COUPLE OF STITCHES. ALTHOUGH THE SURGEON MANAGED TO CONTROL THE BLEEDING FROM THE AORTA, ADDITIONAL BLEEDING WAS OBSERVED FROM AN UNSPECIFIED VESSEL. THE SURGEON WAS EVENTUALLY ABLE TO LOCATE THE SOURCE OF THE BLEEDING; HOWEVER, HE COULD NOT STOP THE BLEEDING COMPLETELY. THEREFORE, A VASCULAR SURGEON WAS CALLED IN FOR ASSISTANCE. IN THE MEANTIME, THE CONSOLE SURGEON USED THE DA VINCI INSTRUMENTS TO APPLY PRESSURE, MOSTLY STOPPING THE BLEEDING. AFTER THIRTY MINUTES, A VASCULAR SURGEON ARRIVED. THE VASCULAR SURGEON WAS NOT A CERTIFIED ROBOTIC SURGEON. HENCE, HIS CONTRIBUTION WAS ONLY VERBAL. THE BLEEDING WAS CONTROLLED (UNSPECIFIED REPAIR WAS PERFORMED) USING THE DA VINCI SURGICAL SYSTEM AND LAPAROSCOPIC INSTRUMENTS. HOWEVER, AFTER HEMOSTASIS WAS ACHIEVED, THE PATIENT'S VITALS DROPPED; AS A RESULT, THE SURGEONS DECIDED TO CONVERT TO AN OPEN SURGICAL PROCEDURE. THE ROBOT WAS UNDOCKED, AND DURING THE CONVERSION TO OPEN SURGERY, THE PATIENT SUFFERED CARDIAC ARREST. THE SURGICAL STAFF STARTED THE EMERGENCY PROTOCOL; HOWEVER, THE PATIENT EXPIRED. IT WAS REPORTED THERE WAS NO MALFUNCTION OF AN ISI DEVICE OR SYSTEM TO HAVE OCCURRED. THE DA VINCI SURGICAL SYSTEM WAS INSPECTED PRIOR TO USE AND NO DAMAGES WERE FOUND AND NOTHING OUT OF THE ORDINARY WAS IDENTIFIED. ON 29-NOV-2021, ISI CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON REVIEWED THE PROCEDURE VIDEO AND CONFIRMED THE FOLLOWING: THAT THE HEM-O-LOK LAPAROSCOPIC INSTRUMENT CAUSED THE INJURY. THERE WAS NO NON-INTUITIVE MOTION OF THE ARM. THE FIRST ASSISTANT DAMAGED THE AORTA WITH THE HEM-O-LOK LAPAROSCOPIC INSTRUMENT WHILE CLIPPING THE RENAL VESSELS. THE SURGEON CONFIRMED THE CAUSE OF DEATH WAS BELIEVED TO BE MYOCARDIAL INFARCTION CAUSED BY THE PREEXISTING MEDICAL CONDITIONS. THE SURGEON COMPLETED THE CONVERSION AND THE PATIENT ENTERED CARDIAC ARREST WHILE THE OPEN SURGERY WAS BEGINNING. THE PATIENT EXPIRED APPROXIMATELY 30 MIN AFTER THE DA VINCI SYSTEM WAS UNDOCKED. IN THIS PERIOD OF TIME THE SURGICAL AND EMERGENCY TEAM TRIED TO PULL THE PATIENT OUT OF THE CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823330 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-38 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES