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

Model Number 380652-38

Device Problems Failure to Sense (1559); Output Problem (3005)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure that the universal surgical manipulator(usm) 3 clutch button became stuck and repeatedly faulted.The usm was disabled to continue with the procedure.The procedure was completed with no reports of patient injury.

Manufacturer Narrative

An intuitive field service engineer (fse) went on site and replaced universal surgical manipulator (usm) 3 to resolve the issue.Intuitive surgical, inc.(isi) has received the usm involved with this complaint; however, failure analysis has not completed their investigation.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted after failure analysis investigation.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) to perform failure analysis.The universal surgical manipulator (usm) was analyzed, and failure analysis investigation confirmed and replicated the customer reported complaint.The usm was tested on an in-house system in normal mode without any errors.The usm was also testing on the patient side cart (psc) fixture test platform (pftp) where insertion buttons test failed because it was found sticky.After a further investigation, contamination was found on the button.

• 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: 18647493
• MDR Text Key: 334630393
• Report Number: 2955842-2024-10971
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-38
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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