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

Model Number 380652-36

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

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 11/04/2021

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the injury and patient expiring is unknown.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 follow up mdr will be submitted if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Verification of the event details via system logs and log reviews cannot be performed at this time because the event date of the procedure is unknown.No image or video clip for the reported event was submitted for review.A medical review was performed by an isi medical safety officer and the following information was provided.Based upon the description in the description of event, there is insufficient information to make a determination if the da vinci system, instrumentation, and/or accessories caused or contributed to the iliac artery injury resulting in a hemorrhage and death.It is unknown what instruments were being used at the time of injury.It is unknown as to what instrument directly injured the iliac artery.The degree of the injury to the iliac artery is unknown.It is unknown what surgical task the surgeon was performing at the time of the injury.The surgeon¿s level of experience is unknown.It is unknown if the surgeon is qualified to perform an arterial repair.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted malignant hysterectomy procedure, there was an injury to the iliac artery which resulted in bleeding.The surgeon elected to convert the case to open; however, the patient subsequently expired.Although there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, the cause of the intra-operative complication is unknown.

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy procedure, an injury to the iliac artery occurred and there was a hemorrhage.The surgeon initially tried to control the bleeding robotically but ended up converting the procedure to open.The patient expired.Intuitive surgical, inc.(isi) made multiple follow-up attempts to contact the surgeon, robotic coordinator, risk management, surgical service director, and executive director of surgical services to obtain additional information.However, no further details have been received as of the date of this report.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

D1001, d1102 - on 22-dec-2021, intuitive surgical, inc.(isi) received the following additional information about the reported event from the surgeon: the name of the surgery was "debulking of lymph nodes." the patient had a previous hysterectomy on (b)(6) 2021 but her lymph nodes were not removed during the previous surgery as the surgeon did not have the right setup and assistant at that time.According ot the surgeon, the patient had difficult anatomy and dissection was difficult due to collateral vessels in the pre-sacral region.During the dissection of the sacral lymph node with the permanent cautery hook (pch) instrument, there was a pinpoint injury to the left common iliac vein measuring 1-2 mm in diameter.There was no allegation that a malfunction of a da vinci system, instrument or accessory occurred at that time.There was no unexpected movements of an instrument and no issues with visualization of the surgical field.The surgeon tried using 5.0 prolene sutures to fix the injury but the injury allegedly got bigger.The surgeon applied pressure with the fenestrated bipolar forceps (fbf) instrument and tried to suture the injury again.Around this time, the patient's end tidal co2 levels dropped and the patient had a cardiac arrest.In order to resuscitate the patient, the surgeon had to undock the robot.The fbf instrument which was clamped onto the bleeding vessel had to be released.The procedure was converted to open at this stage so that the surgeon could apply pressure by hand to the bleeding vessel.The resuscitation efforts failed and the patient expired on the table.An autopsy was performed on the patient and the cause of death was a saddle pulmonary embolism.The surgeon stated that the patient had risk factors for pulmonary embolism such as poor activity level, metastatic cancer, obesity and a recent robotic surgery performed for hysterectomy.The surgeon believed that the cause of death was a pulmonary embolism.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Additionally, all reusable instruments used in the case were used in subsequent procedures with the exception of the large needle driver and a site review shows no complaint filed against the instruments.A medical review was conducted by an isi medical safety officer (mso) and the following findings were obtained: based upon the information in the description of events, an injury to the left iliac vein occurred during a lymph node dissection leading hemorrhage.The surgeon elected to attempt a robotic repair of the left iliac vein robotically.The attempted iliac vein repair by the surgeon increased the size of the injury to the left iliac vein.The surgeon maintained some control of the bleeding through the use of direct pressure.While the surgeon was preparing to re-attempt a robotic repair of the vein, the patient¿s end tidal co2 levels dropped and went into cardiac arrest.The robotic system was emergently undocked and resuscitative measures were initiated.The procedure was emergently converted to open in order to control the hemorrhage.The patient unfortunately expired.A saddle embolism was found during autopsy.The cause of the left iliac vein injury is not exactly clear.It is unknown if the injury to the left iliac vein occurred due to direct mechanical trauma (puncture or a laceration) or due to a thermal injury while the surgeon was performing the lymph node dissection.Additionally, it is also unknown what type of needle the surgeon was given to attempt the vascular repair.Provided that the da vinci system, instrumentation, and/or accessories performed as expected and the surgeon felt comfortable with the established visual field, it is likely that this event (injury to the left iliac vein leading to death) is rooted in use error that may have been complicated by the patient¿s anatomy and past medical history.

• 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: 12995439
• MDR Text Key: 282179671
• Report Number: 2955842-2021-11739
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-36
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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: 78 YR
• Patient Sex: Female