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

Model Number 380652-50

Device Problem Insufficient Information (3190)

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

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted general surgical procedure, the surgeon converted to open surgery due to a patient anatomy issue.Intuitive surgical inc.(isi) followed up to obtain additional information.The system functionality was checked upon powering on, and it initially did power on without errors.The procedure was completed.No arms were disabled/discontinued.The procedure was then converted to open surgery because of a patient anatomy issue which was the surgeon's decision and not due to a da vinci malfunction issue.

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse identified that universal surgical manipulator (usm) 3 had a repeated 23007 fault.The fse replaced the usm.The system was tested and verified as ready for use.Isi did receive the usm involved with this complaint; however, failure analysis has not completed their investigation.No arms were disabled/discontinued, and it was confirmed that the procedure was converted to open surgery because of a patient anatomy issue which was the surgeon's decision and not due to a da vinci malfunction issue.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) and performed failure analysis.The usm was tested on an in-house system and failed in normal mode with errors triggered.The unit passed multiples tests but failed the carriage direction test on degrees of freedom (dof) 5.After further investigation, the dof 5 gearbox was stuck and not moving causing an error which confirms the issue happening in the field with multiple errors.Dof 5 and dof 9 stators were found with melted material.

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: 18273792
• MDR Text Key: 329828745
• Report Number: 2955842-2023-20911
• Device Sequence Number: 1
• Product Code: NAY
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2021
• 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