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

Model Number 380652-41

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

Patient Problems Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 01/04/2021

Event Type  Death  

Event Description

It was reported that after a da vinci-assisted sleeve gastrectomy procedure performed on (b)(6) 2021, the patient expired on (b)(6) 2021.The surgeon said that during the da vinci procedure, there were no system errors.There was no report of a da vinci system, instrument, or accessory malfunction during the da vinci procedure.The surgeon does not feel that the da vinci system, instrumentation, and/or accessories caused or contributed to the event.Per the surgeon, the system did not do anything unexpected.There was no unexpected system or instrument movement and all instruments and system functionality worked as intended.The procedure was completed robotically without incident and there were no immediate post-operative complications.The surgeon stated that the patient was seen by a nutritionist on (b)(6) 2021 and, ¿all was good.¿ then, two weeks post-operatively, the patient said he was not feeling bad but the surgeon met the patient at the hospital emergency room (er) on (b)(6) 2021 for an examination.The patient progressively started ¿feeling really sick¿ and a ct scan identified a ¿massive portal metastatic vein thrombosis (pmvt)¿ that ended up ¿infarcting the entire gut.¿ according to the surgeon, the ¿abdomen filled up with fluid¿ and ¿the gut died which caused the patient to expire.¿ the surgeon attributed the cause of the event and the patient¿s death as being due to a hypercoagulable event that couldn¿t be seen before symptoms presented and was caused by morbid obesity, dehydration, and the acute presence of clots.The surgeon reiterated that this would have been ¿undetectable prior to the clotting event.¿.

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported event cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site history complaint review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted by the customer to isi for review.A system error log review was conducted on 20-jan-2021 for a procedure on (b)(6) 2021 on 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.All reusable instruments used in the case have been used in subsequent procedures.A site review shows no complaint filed against the instruments in use during the procedure.A review of the event information provided was conducted by an isi medical safety officer and the following was noted: the patient developed portal vein thrombosis after undergoing a da vinci assisted sleeve gastrectomy on (b)(6) 2021.Portal vein thrombosis is a rare but serious problem with high morbidity and mortality following minimally invasive sleeve gastrectomy procedures with a reported incidence of 0.3% to 1%.Portal vein thrombosis is most associated with the minimally invasive sleeve gastrectomy but may occur with other abdominal surgical procedures such as roux-en-y gastric bypass.Portal vein thrombosis typically presents approximately two to three weeks after the primary procedure.The dominant presenting symptom is abdominal pain followed by fever.The development of portal vein thrombosis is not associated with a device failure, malfunction, improper or inadequate design, manufacturing, labeling, or use error.Portal vein thrombosis does not result from a mistake made the person using the device.After a da vinci assisted sleeve gastrectomy procedure, the patient presented to the hospital with a pmvt and ultimately expired on post-operative day #13.The surgeon does not believe the da vinci surgical system caused or contributed to the event.The surgeon attributed the cause of the event and the patient¿s death as being due to a hypercoagulable event that couldn¿t be seen before symptoms presented and was caused by morbid obesity, dehydration, and the acute presence of clots.This mdr is being submitted as part of a retrospective complaint review.

• 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: 13256655
• MDR Text Key: 283808538
• Report Number: 2955842-2022-10056
• 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: 01/18/2021

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: 380652-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2019
• 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: 41 YR
• Patient Sex: Male