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 11/05/2021

Event Type  Death  

Event Description

It was initially reported that during a da vinci-assisted esophagectomy (non-transthoracic - transhiatal) procedure, the surgeon hit the inferior vena cava (ivc) while trying to take down adhesions and separate the liver from the diaphragm.The patient reportedly died due to blood loss.On 05-nov-2021 an intuitive surgical inc.(isi) clinical sales representative (csr) was contacted to learn more on this reported event: the csr who reported this event was present during the procedure that took place on (b)(6) 2021.The csr said this was the surgeon¿s first esophagectomy using the da vinci surgical system.A cardiothoracic surgeon was also present during the procedure observing in case anything went wrong.It is unknown if the cardiothoracic surgeon was a proctor.The console surgeon was using a vessel sealer extend (vse) in the right hand and a fenestrated bipolar instrument in the left hand.The surgeon was using the fenestrated bipolar instrument to hold unspecified tissue down, creating tension, and then using the blunt vse instrument to take down adhesions.The csr reported that the surgeon thought he was near the diaphragm removing adhesions with this technique when the cardiothoracic surgeon said something about the console surgeon needing to be careful as they were near the cava.The csr reported that just after the cardiothoracic surgeon made this statement, the console surgeon struck the cava with the vse blunt edge and it began to bleed.The console surgeon used the vse instrument to "clamp down" on the bleeding vessel and started the process to convert to open.It is unclear if the surgeon used the vse to press down on the ivc or if he used the jaws of the vse to grab the ivc.The or staff kept the vse instrument docked and holding the bleeding vessel while converting to open.After converting to open, the or staff grabbed the bleeding vessel with a non-robotic surgical instrument.Once the non-robotic instruments were in place to control the bleeding ivc, the da vinci system was entirely removed.At this point, the csr left the room.The csr was told via text message later that same day by the console surgeon that the patient coded three times and ultimately passed away.The surgeon reported to the csr that he does not think a da vinci product caused or contributed to this event.The surgeon reported that this patient was very old and had multiple comorbidities.The surgeon reported to the csr that this patient was a high risk patient for this procedure.Isi performed multiple follow-up attempts to obtain additional information from the surgeon of this procedure; however, as of the date of this report, no further details have been received.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.A review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure.Additionally, only the 30 degree endoscope and large needle driver used during this procedure were used in subsequent procedures.The following instruments were used during this procedure and not used in subsequent procedures: the tip-up fenestrated grasper (part number: 470347-11 / lot number: n10191014-0085 / uses remaining: 4), the fenestrated bipolar forceps (part number: 471205-17 / lot number: n10201020-0163 / uses remaining: 2).The monopolar curved scissors instrument used during this procedure had no uses left after this procedure.The vse instrument used during this procedure is a single use instrument and therefore could not be used in subsequent procedures.No images or videos were obtained for this reported event.A site history complaint review was performed and no additional complaints related to this product/event were identified.A medical review of event information provided was performed by an isi medical safety officer and the following was noted: based upon the information in the description of events, the console surgeon with limited robotic esophagectomy experience mechanically injured the patient¿s inferior vena cava during blunt dissection.The inferior vena cava was either torn or punctured as a result of the mechanical trauma from the vessel sealer.By the account via the reported comments from the cardiothoracic surgeon, it seems as if the surgeon was not familiar with the proximity of the inferior vena cava at the time of the injury.The inferior vena cava began to bleed.The surgeon reactively converted to the procedure to an open procedure in an attempt to control the bleeding and repair the inferior vena cava.The patient unfortunately did not tolerate the acute blood loss anemia and subsequent hypotension/hypoperfusion and died.This event is being reported due to the following conclusion: during a da vinci-assisted esophagectomy (non-transthoracic - transhiatal) procedure, the patient expired due to the ivc being struck, causing the patient to bleed.The surgeon reported that they do not believe this event was related to a da vinci product; however, at this time, it is unknown to what degree the da vinci system, instruments, and accessories used during this procedure may have caused or contributed to the event.

• 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: 12929874
• MDR Text Key: 281729106
• Report Number: 2955842-2021-11660
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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 Age: 81 YR