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

Model Number 380652-48

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/16/2023

Event Type  Death  

Manufacturer Narrative

There was no report of any malfunction of an intuitive davinci system, instrument or accessory occurring during the procedure; no product is expected to be returned for evaluation.The instruments noted below were used during the reported procedure.Review of the instrument logs found that the following multiple use instruments were used in subsequent procedures after the event date with no reported complaints: endoscope 0 degree camera, endoscope 30 degree camera, monopolar curved scissors, cadiere forceps.The forceps bipolar with dual grip has lives remaining but has not been used in subsequent procedures.Review of the system logs found no relevant errors logged during the procedure.Multiple procedures have been performed on this system and review of the logs for the subsequent 5 procedures also found no relevant errors.A device history record (dhr) review for the device(s) involved with the reported event confirmed there were no non-conformances related to this complaint.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that the cause of death was massive bleeding which reportedly occurred after the robot was undocked and during removal of the specimen.The cause of the bleeding, which vessel bled, and the details surrounding the event are unknown.Based on the information provided, there is insufficient information available to determine if any intuitive surgical products or instruments contributed to this event.

Event Description

It was reported that during a da vinci-assisted nephroureterectomy surgical procedure for a malignant tumor of the ureter, the patient experienced excessive bleeding and expired on the day of surgery.The resection of the kidney and ureter was completed and the davinci system was ¿rolled out¿.The massive bleeding occurred when the resected kidney was removed from the body prior to wound closure.Information regarding the cause, specific location, and any interventions performed for the observed bleeding was not known by the report source.No additional information was provided.

• 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: 18490418
• MDR Text Key: 332600901
• Report Number: 2955842-2024-10230
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• 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: 12/15/2023

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
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• 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