MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 09/16/2021

Event Type  Death  

Manufacturer Narrative

The root cause of this event has been determined to be related to difficult patient anatomy and placement of a third party trocar.There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.A system error log review was conducted for the procedure performed on (b)(6) 2021 using system (b)(4).There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.All reusable instruments used in the case have been used in subsequent procedures and a site history search shows no complaints filed against the instruments.An isi advanced failure analysis (afa) engineer conducted additional system log review and found that all of the errors in the logs for that procedure are class 0 (system service advisory (no fault reaction)) and class 8 (engineering event informational (no fault reaction)) so none of these would suggest a product issue.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.No image or video clip for the reported event was submitted by the customer to isi for review.A review of the event information provided was conducted by an isi medical safety officer and the following was noted: based on the information in the description of events above, the patient died due to complications due to an injury from a third party optical trocar that was used by the surgeon to gain initial access into the abdominal cavity in a patient with morbid obesity.The injury that caused the hemorrhage likely resulted from the depth the initial third party optical trocar was placed surgeon.Although the surgeon indicated that an injury resulting from the third party trocar was suspected, the injury was not immediately identified by the surgeon.At this point, the surgeon elected to place the robotic trocars and dock the da vinci system.Due to the patient¿s body habitus and anatomy, the surgeon was unable to proceed with the planned da vinci assisted cholecystectomy.Eventually, the surgeon noticed blood within the intra-abdominal cavity.The surgeon was informed by the anesthesia team that patient¿s blood pressure was becoming unstable.The surgeon decided to perform an open laparotomy to identify the possible source of the bleeding.The bleeding, that resulted from the initial third party optical trocar placement, that required multiple blood transfusions eventually led to the patient¿s death.The patient¿s death not related to a da vinci system, instrument, and accessory error.Additionally, the initial attempt by the surgeon to gain access into the abdominal cavity using a third party optical trocar contributed to the injury.Prior to the start of a da vinci-assisted surgical procedure, the patient experienced bleeding as a result of initial third party optical trocar placement.The da vinci was then docked to gain vision and attempt troubleshooting, but was ultimately undocked to convert to open surgery.The patient ultimately expired.This mdr is being submitted as part of a retrospective complaint review.

Event Description

It was reported that prior to the start of a da vinci-assisted cholecystectomy procedure, the surgeon made her first port entry with a non-isi third party optical trocar.The surgeon said that she ¿went in with the trocar¿ but ¿went in a little too deep.¿ the surgeon did not see any issue at the moment of trocar insertion and there was no known initial visible bleeding so the surgeon continued placing ports and docked the da vinci system to the patient.As the surgeon started working, she could see that visibility was poor; the surgeon said that there were visibility issues due to patient anatomy.The patient was reported as being ¿very heavy; (b)(6) lbs.¿ making visibility of anatomy difficult and the surgeon was unable to see the gallbladder.As the surgeon continued, she could see ¿some bleeding¿ and she initially thought she could ¿place a drain versus going open¿ but when the surgeon ¿came out with instruments,¿ the anesthesiologist said that the patient had a low blood pressure (bp).The procedure converted to open surgery and the surgeon found that bleeding was coming from ¿a vessel in the mesentery; a vein.¿the surgeon said that she realized that she had ¿gone down too deep with the trocar¿ and it caused a small tear in the vein; resulting in the vein bleeding.The surgeon was able to ¿evacuate the blood¿ and apply sutures to control the bleeding.The surgeon said that, while the patient lost approximately 2,300 ccs of blood over a 20 minute period during the open surgery, it was a minor injury and that ¿back pressure from cirrhosis made everything worse.¿ the initially planned cholecystectomy procedure could not be completed due to patient anatomy.The patient was administered four units of 0-negative blood, was ¿closed¿, and was then taken to the intensive care unit (icu).While in the icu, the patient¿s bp ¿stayed soft.¿ the surgeon said that the patient was administered medication to increase blood pressure; they gave ¿one, two, then three pressors.¿ the patient was given six liters of fluid.The next morning, on (b)(6) 2021, due to lab levels and the patient¿s bp, it was suspected that the patient was still bleeding.A second open exploratory reoperation was performed.There was no active bleeding found during the reoperation.It was determined that the patient had gone into ¿dic¿ (disseminated intravascular coagulation).The patient was closed and was transported back to icu.Later that morning, the patient pupils were found fixed and dilated and the family withdrew care.The patient expired on (b)(6) 2021.The surgeon said that ¿there were no robot issues,¿ that the ¿robot wasn¿t even docked¿ upon first port entry, that ¿the robot was not the cause of this injury,¿ and that there were no issues with a da vinci product.The surgeon also indicated that "everything worked fine.¿ the surgeon said that the cause of death was ¿complications from the initial blood loss, then dic¿ with a ¿contribution of cirrhosis.¿ again the surgeon said, ¿the back pressure from the cirrhosis just made everything worse.¿.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13256663
• MDR Text Key: 283808362
• Report Number: 2955842-2022-10060
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Weight: 204 KG