MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer reported that the arm1 was locked and would not move when starting the robotic system.A message was displayed that "arm1 was not free to move".There was error 25326 on patient side manipulator (psm) 1 / remote arm controller (rac) 1.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon disabled and/or discontinued the use of the arm due to the issue.The procedure was not completed with four arms.The arm that presented the problem was deactivated and the procedure continued with the other arms.The customer did not answer if ports were placed at the time of the issue.System functionality was checked upon powering on the system and the system initially powered on without errors.The customer inactivated the arm with the problem and the procedure continued without further complications.The procedure was completed robotically using the same system.Patient information was requested but could not be provided.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting arm errors, an investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the patient side manipulator (psm) 2 and the remote arm controller (rac) to resolve the issue.The system was tested and verified as ready for use.Isi did not yet receive a da vinci product involved with this complaint to perform failure analysis.The complaint was confirmed based on the field evaluation, which indicates that the device did contribute to the customer reported issue.A review of the system logs associated with this event has been performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the fae reviewed the system logs for rhs0277 on 2023.There are no occurrences of 25326 errors.On this date, there are no indications of fault with the system.The first instance of the 25326 error occurred on 25-apr-23.On this date, a significant communication fault was logged prior to starting a procedure.Note that this event did not contain the 25326 error, but rather 23, 40, 25100, 25116, and 40084 (all communication faults).The system was powered cycled with no errors reoccurring on start-up.A procedure was begun and after 2.5 hours, the aforementioned communication errors were triggered with the addition of the 25326 error (related to communication).The logs then show that the procedure was ended after the system was powered off for an extended period of time.All of these errors are sympathetic to each other and indicate a communication fault stemming from the rear core fiber port (as reported by the logs).Also, during this event, the fae can see no indication that an arm was disabled.This complaint is being reported based on the following conclusion: a psm was disabled/abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a conversion/abortion.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci products involved with this complaint to perform failure analysis.The remote arm controller (rac) was analyzed and found to have no failures.The unit was tested during an in-house testing and no failures was observed.The complaint regarding errors on rac 1 was not confirmed based on failure analysis.The patient side manipulator (psm) 2 was also analyzed and confirmed to have non-intuitive failure during in-house testing.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The returned remote arm controller (rac) was further inspected, and oxidation/contamination was identified at the gold plate internal to the controller.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 16950870
• Report Number: 2955842-2023-13700
• Device Sequence Number: 7040924
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 04/03/2024
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/13/2023; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown