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

Model Number 380652-48

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Bowel Perforation (2668); Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Death  

Manufacturer Narrative

Due to insufficient information, the reported robotic procedural details were unable to be confirmed, and review of system and instrument logs were unable to be performed.The report source requested anonymity.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that based on the available information, the patient underwent an inguinal hernia repair followed by multiple complications.There were no reported issues or malfunctions at the initial procedure regarding any intuitive surgical products or instruments.Multiple non-robotic procedures ensued and the patient ultimately developed a bowel perforation with eventual death.When or how the perforation occurred, and how it may or may not have been related to the initial procedure are unknown.Based on the information provided, insufficient information is available to ascertain if any intuitive surgical products or instruments contributed to this event.Section b2 date of death: the report source stated the surgical procedure occurred near the end of (b)(6) 2023, and the other complications occurred over approximately 2 weeks.The date of death is left blank; however, estimated date of death would be approximately the (b)(6) 2023.Section e1 reporter: the report source requested anonymity.

Event Description

It was reported that after a da vinci assisted right inguinal hernia repair, the patient expired.The patient returned to the er with an unknown chief complaint, on an unknown post-operative day (pod).The findings of the visit, or interventions performed are unknown aside from the placement of a foley catheter.The patient was discharged home, but returned to the er for a second time with additional unspecified complications and an elevated white blood cell (wbc) count.A diagnostic laparoscopy was performed due to concern for an incarcerated hernia; the patient was again discharged to home.The patient returned to the er for a third time where a different surgeon performed a second exploratory laparotomy with bowel resection.The patient was later discharged home.The patient returned to the er for the fourth time after the original surgery and a second exploratory laparotomy was performed.During this operation, it was discovered that the patient had a perforated bowel spilling contents into the abdomen.The patient was also reported to have been diagnosed with a clostridium difficile infection and had been placed on dialysis.At an unknown time, the patient went into cardiac arrest and expired.It was reported that these complications occurred over the course of about two weeks.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Section b5 additional information: a final statement from the hospital risk management concluded that, "after a comprehensive investigation and review, our findings revealed no deviations and/or device concern related to this inquiry.Our findings indicated that all protocols employed during this surgical procedure were adhered to and that there were no issues identified during this procedure.".

• 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: 18178548
• MDR Text Key: 328609225
• Report Number: 2955842-2023-20253
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

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: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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 Sex: Male