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

Model Number 380652-54

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

Patient Problems Failure to Anastomose (1028); Insufficient Information (4580)

Event Type  Death  

Event Description

It was reported that after a da vinci-assisted pancreaticoduodenectomy (whipple) procedure, the patient developed a leak and expired.Information regarding the location of the leak, the instruments used in the affected area, any intraoperative complications, the span of time from the procedure to the patient's demise, and any other details were not provided.

Manufacturer Narrative

Additional information was requested; however, no further details have been provided.Due to the unknown procedure date and the limited information available, a review of system logs, instrument logs and device history record review cannot be performed.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that a patient developed a leak following a robotic whipple procedure and ultimately expired.The details regarding the procedure and post operative course are unknown.The cause of death is also unknown.Insufficient information exists to determine 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: 18253117
• MDR Text Key: 329547951
• Report Number: 2955842-2023-20755
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-54
• 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: 11/07/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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