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

Model Number 380652-40

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 10/18/2023

Event Type  Death  

Event Description

It was reported that after a da vinci-assisted sleeve gastrectomy procedure, the patient expired.The procedure was completed robotically.The patient was taken to the postoperative anesthesia care unit (pacu), where they began to lose blood.The patient was monitored for several hours and then brought back into the or to re-operate and find the bleeding source with an open procedure.

Manufacturer Narrative

Multiple attempts to obtain additional information have been made; however, no response has been received.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that based that the patient died as a result of a bleeding following a sleeve gastrectomy procedure.The details of what vessel or area was bleeding were not provided nor was how this bleeding may have occurred.Based on the limited information provided, insufficient information exists to determine if any intuitive surgical products or instruments contributed to this event.

Manufacturer Narrative

Section b5 additional information: the patient was monitored for several hours.At some point, resuscitation was performed, and the patient was brought back into the or to re-operate and find the bleeding source with an open procedure.No additional information was provided.The operating surgeon performed two sleeve gastrectomy procedures on the same date with the same da vinci system.There is insufficient information to discern which operative data correlates with this reported event.Therefore system and instrument logs information cannot be provided.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18166600
• MDR Text Key: 328477054
• Report Number: 2955842-2023-20472
• 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,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: 380652-40
• Device Catalogue Number: 380652
• 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: 11/18/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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.