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

Model Number 380620-37

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Lactate Dehydrogenase Increased (4567)

Event Date 11/20/2023

Event Type  Death  

Manufacturer Narrative

The instruments noted below were used during the reported procedure.Review of the instrument logs found that the following multiple use devices were used in subsequent procedures after the event date: fenestrated bipolar forceps, cadiere forceps, monopolar curved scissor, maryland bipolar forceps, large needledriver, small clip applier and the endoscope 30 degree camera.A medium clip applier and the large clip applier have lives remaining but were not yet used in subsequent procedures.The synchroseal, sureform 45 stapler and sureform 60 stapler are single-use items.A site history review shows no complaints filed against any of the instruments or the endoscope.Review of the davinci system logs found no errors were logged during the procedure.The system has been used multiple times subsequent to the reported event; log review of the 5 subsequent procedures performed also found no relevant errors.Device history record review for the devices confirmed that there were no non-conformances identified.Stapler logs showed that the sureform 60 stapler was used first and was installed on the system twice.With the first install, after a few incomplete/aborted clamping attempts, the firing of a green reload was completed successfully.With the second install, the first clamp was successful and the firing of another green reload was successfully completed.The logs showed that the sureform 45 stapler was later installed on the system twice and fired two blue reloads; both firings were completed successfully.There were no stapler related errors in the master logs.A review of the advanced energy logs show there were 10 coagulation events with no errors, and 101 seal events and 105 transect events with no related errors.An intuitive surgical medical safety officer review of the available information concluded that the patient died after an unknown period of time following a robotic whipple procedure.The cause of death and the details surrounding the patient¿s post operative course are unknown.There is insufficient information available to determine if any intuitive surgical products or instruments contributed to this event.

Event Description

It was reported that after a da vinci-assisted pancreatoduodenectomy (whipple) procedure, the patient subsequently died at an unspecified time after experiencing cardiac arrest.The day after the procedure, the patient¿s lactate levels were elevated and the patient was returned to the operating room for an unspecified second procedure.No information was provided regarding the cause of the elevated lactate levels, the operative findings, the cause of the cardiac arrest, or any medical or surgical interventions administered.

• 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: 18451634
• MDR Text Key: 332180056
• Report Number: 2955842-2024-10073
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171294
• 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
• Report Date: 12/12/2023

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: 380620-37
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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