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

Model Number 380620-41

Device Problem Insufficient Information (3190)

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

Event Date 10/16/2023

Event Type  Death  

Event Description

It was reported that during a da vinci-assisted donor partial hepatectomy procedure, the patient expired.The procedure was nearing completion when heavy bleeding started and there was an immediate conversion to laparotomy.The origin of the bleeding was the hepatic portal vein and/or the inferior cava.Cautery and suturing were performed to control the bleeding.There was approximately 2l of blood loss.The patient received ¿countless¿ bags of packed red blood cells and plasma.The patient progressed to cardio-respiratory arrest and after approximately one hour of unsuccessful attempts at resuscitation the patient expired.The report source stated that there was no product quality deviation considered; the robotic system remains in use with no reports of any problems.

Manufacturer Narrative

Review of the system log for the reported procedure found no relevant system errors.Review of the 3 subsequent procedures performed with system also found no errors that would have caused or contributed to an adverse event.A review of the device history records (dhr) found no non-conformances were identified to be related to this event.Review of the instrument logs found that the following multiple use instruments were used during the procedure and a site review found no reported complaints: 30-degree endoscope plus, maryland bipolar forceps, cadiere forceps, harmonic ace, monopolar curved scissors.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that the patient was nearing completion of a partial hepatectomy when there was significant bleeding from an unconfirmed source.As a result of the injury, the patient had a catastrophic bleeding event and expired.No allegation of any intuitive surgical products has been made.Based on the information provided in the summary of events, insufficient information is available to ascertain if any intuitive surgical products or instruments contributed to this event.

Manufacturer Narrative

Section b5 additional information: the procedure was a left hepatectomy in the left lobe of the liver.When the bleeding complication occurred, the surgeon was performing a liver release and dissection of the hepatic hilum lymph nodes.It was noted that the hepatic release and dissection of the hepatic hilum lymph nodes had been completed prior to the bleeding complication occurring.The transection of the liver was the planned next step.

• Brand Name: DAVINCI X
• 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: 18146612
• MDR Text Key: 328222812
• Report Number: 2955842-2023-20382
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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: 380620-41
• Device Catalogue Number: 380620
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White