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

Model Number 380652-50

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The issue was addressed with phone support.An intuitive surgical, inc.(isi) field service engineer (fse) followed up with the customer and the customer confirmed that the surgeon's hands were not on the manipulators while the head was still in the viewer, enabling the instrument to be moved easily.A review of the site's system logs for the reported procedure date was conducted by failure analysis engineer.Investigation revealed the following possible related system errors: in the logs an error was identified which indicates that the surgeon may have removed their hand while in following which aligns with the complaint.This isn¿t an issue with the system or instrument.

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, while the bedside assistant was attaching an energy cord to an instrument while engaged in the universal surgical manipulator (usm) the instrument advanced.The site states the surgeon had control of the instrument at the time of the event.It was noted the surgeon's head was engaged in the console at the time of the event, but their hands were removed from the master tool manipulator (mtm).The instrument bluntly made contact with tissue however, no bleeding, tissue damage, tissue resection or intervention of any kind was required.The procedure was completed robotically with no system errors or complications.

• 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: 18140069
• MDR Text Key: 328167607
• Report Number: 2955842-2023-20247
• 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
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES