MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; BLUNT OBTURATOR

Model Number 470008

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152); Thrombosis/Thrombus (4440)

Event Date 02/01/2024

Event Type  Death  

Manufacturer Narrative

Additional information was requested; however, none has been provided.The da vinci system was never docked to the patient prior to the conversion to open for the aortic repair and subsequent ostomy procedure.Therefore, there are no system logs available for review.A review of the event performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report suffered a trocar injury to the aorta at the beginning of the procedure.While the robot was never docked and the case was then converted to open, it is unknown if the trocar that created this injury was an intuitive product.The injury was repaired but the patient then went on to have unspecified thrombotic events.The details surrounding the death the next day are also unknown.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive surgical products or instruments contributed to this event.

Event Description

It was reported that during placement of the ports at the start of a da vinci-assisted procedure, the surgeon successfully inserted a 3rd party visiport optical trocar.When a second unspecified trocar was inserted the aorta was injured resulting in bleeding.The procedure was converted to open and the aorta was repaired with sutures with the assistance of a vascular surgeon.The patient had calcifications in the aorta, and after the aortic repair, they experienced issues with thrombosis.The originally scheduled da vinci-assisted procedure was a rectopexy.However, after conversion and the aortic repair, the surgeon elected to proceed with the creation of a stoma.The procedure reportedly went well, and the patient was transferred to recovery.The patient was pronounced deceased the following morning due to complications related to thrombosis.

Manufacturer Narrative

Section b5: additional information: the first port site placed was via a medtronic visiport plus, then insufflation was introduced.Then two da vinci 8mm standard ports were placed under visualization in a semi-circular line from the pubic bone.The surgeon confirmed that the aorta was lacerated during the placement of the second port.Due to the presence of plaque, it was not possible to compress the aorta, therefore, the damage to the aorta was repaired with sutures.The estimated amount of blood loss as a result of this injury was 1 l.The patient was transfused with 4 units of blood.It was initially reported that a stoma was created rather than completing the rectoplexy as planned; however, the surgeon clarified that the patient was scheduled for both a rectopexy and an end colostomy.The surgeon confirmed that the patient passed away 12 hours after the procedure was completed due to complications related to thrombosis.The thrombi were located within common iliac vessels and were likely due to detached plaque from trying to compress the aorta.The cause of death was thrombosis on (b)(6) 2024.The da vinci system was never docked to the patient at any point.A review of the additional information was performed by an intuitive medical safety officer (mso) who concluded that according to the information provided in the summary of events, the patient in this report had a port placement aortic injury while placing an intuitive surgical port.An open repair was attempted.A thrombosis of the iliac vessels then occurred when attempting to obtain vascular control.The robot was not docked at any time during this procedure.However, the port used which created the injury was an intuitive surgical product and therefore may have contributed to this catastrophic event.The instructions for use for the da vinci xi systems contains the following cautions to minimize the risks associated with port placement.Caution: to minimize the risks associated with port placement ensure the following to prevent tissue injury: appropriate patient positioning to shift organs away from the port placement site.An adequate level of insufflation.Obturator tip is pointing away from major vessels, organs, and other anatomic structures.When possible, visualization of the entire insertion of the cannula using the endoscope is preferred.Utilize continuous, controlled pressure with a deliberate rotating motion when placing the cannula and obturator.

• Brand Name: NONE
• Type of Device: BLUNT OBTURATOR
• 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: 18812865
• MDR Text Key: 336601340
• Report Number: 2955842-2024-11941
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470008
• Device Catalogue Number: 470008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES