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

Model Number 380620-45

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication cannot be determined.No product has been returned to intuitive surgical, inc.(isi) for evaluation.A review of the site's system logs for the reported procedure date was conducted by an isi regulatory post-market surveillance (rpms) analyst.Per the investigation, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that a da vinci-assisted pulmonary lobectomy procedure was converted to open due to bleeding.The bleeding was not related to the robotic system.The surgeon did not anticipate the possibility of converting the procedure due to patient anatomy prior to the start of the procedure.Additional information was requested by intuitive surgical, inc.; however, all clinical questions relating to the bleeding, the patient's anatomy and condition, and any further complications were not answered by the customer, as "they concern the medical side.".

• Brand Name: DAVINCI X
• 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: 19067556
• MDR Text Key: 339672398
• Report Number: 2955842-2024-13187
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380620-45
• Device Catalogue Number: 380620
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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