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

Model Number 380652-35

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Sepsis (2067); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2023

Event Type  Death  

Event Description

It was reported that after a da vinci-assisted gastrostomy surgical procedure, the patient expired.The surgeon confirmed that during the robotic gastrotomy procedure, there were no issues, errors, or complications specifically with the da vinci system or products.The patient also had no intraoperative complications.The patient had terminal esophageal cancer with a large mass, was on a third round of chemotherapy, and per the surgeon was at high risk for complications.The patient required a surgically placed gastrostomy tube (g-tube) due to an unsuccessful attempt to place a percutaneous endoscopic gastrostomy (peg) tube due to the large cancerous mass.The g-tube was surgically placed with no complications, it was secured using the stamm technique, which included suturing, and the balloon of the g-tube was instilled with 6ml of sterile water.Placement was tested and verified prior to completion of the procedure.The patient was discharged home the same day.The surgeon reported that the patient did not experience any complications with the g-tube directly postoperatively or later that night.The patient went to the cancer center the following day for chemotherapy, to receive instructions for tube feedings, and to administer a feeding during the appointment.However, a tube feeding was not administered as it was noticed that stomach contents were leaking out of the g-tube and the patient was dizzy, experiencing abdominal pain, and was tachycardic.The patient was transferred to the emergency room.A ct scan found that the balloon of the g-tube was deflated and the tube was pulled back, out of place.The patient was brought back to the operating room for laparoscopic surgery and g-tube revision.The g-tube tip was found at the edge of the abdominal wall.During this second procedure, the surgeon took the stomach down and stapled off both the previous hole that was made for the original g-tube and where the evidence of the leaking was coming from.A new g-tube was placed within a healthy part of the stomach.During the procedure, the original g-tube balloon was tested with no complications observed; it was unclear what caused the first g-tube to fail as the balloon remained intact and could inflate and hold the seal.The contents of the abdomen were washed out and the patient was sent to the intensive care unit (icu).The patient subsequently became septic, and their status began to decline.The patient was ultimately unable to recover from the sepsis and expired the following morning.

Manufacturer Narrative

The instruments noted below were used during the reported procedure.Review of the instrument logs and site history found that the multiple-use 30 degree endoscope was used in subsequent procedures after the event date with no reported complaints.The multiple use permanent cautery hook, fenestrated bipolar forceps, prograsp forceps, and mega suture cut needle driver have not been used in subsequent procedures; there were no reported complaints for any of these instruments.A device history record (dhr) review for the device(s) used during the procedure found no non-conformances were identified to be related to this event.A review of the system logs for this procedure found no errors that would be related to this event.A review of the logs for the 4 subsequent procedures performed with the system after this procedure also had no relevant errors.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that the patient in this report had a gastrostomy tube (g-tube - 3rd party device) placement procedure.The g-tube has a balloon which holds it in place in the stomach once inflated.They also performed this procedure as a stamm gastrostomy which secures the stomach to the anterior abdominal wall.Despite the additional securing method by using the stamm gastrostomy technique, the balloon somehow deflated and the g-tube became dislodged from the stomach, and the stomach fell away from the anterior abdominal wall.In this situation, gastric contents would leak into the abdomen plus anything placed through the g-tube would go into the abdominal cavity and not the stomach.This type of event can create sepsis as well as profound fluid shifts.The cause of the 3rd party g-tube balloon failure is unknown.The stamm portion of the procedure also did not adequately prevent leakage, although it appears the stomach was still partially attached to the anterior abdominal wall.While the cause of these failures is unknown, no allegation has been made against any intuitive surgical products or instruments.Based on the information provided in the summary of events, there is insufficient evidence to ascertain if any intuitive surgical products or instruments contributed to this event.

• 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: 18146205
• MDR Text Key: 328222841
• Report Number: 2955842-2023-20328
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-35
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White