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

Model Number	380686-04
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional 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 replaced remote arm controller (rac) to resolve the issue.The system was verified and ready to use.Isi has not received the rac for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal with lymphadenectomy prostatectomy surgical procedure, repeated non-recoverable error 25580 occurred on endoscopic camera manipulator (ecm).The site received phone assistance from intuitive surgical, inc.(isi) technical support engineer (tse).Tse had site perform a hard power cycle on the system, but repeated non-recoverable error 40006 pointing to remote arm controller boards (rac) 3 of the endoscopic camera manipulator (ecm) occurred after the hard power cycle.Tse had site perform power cycle the system one more time, but the issue persisted.The surgeon elected to convert the procedure to laparoscopic surgery.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the conversion did not result in increasing port size incision and no additional ports.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The remote arm controller (rac-10) was analyzed, and the reported errors were confirmed and replicated.In the system logs, the errors 25580, 25581and 40006 were found confirming the faults occurred in the field.Upon visual inspection, no issues were found that would be related to reported event.The unit was installed onto a golden system where was triggered indicating fault on the rac-10.Then the system was set to run 10 minutes sine cycle, 10 power cycles and failed with intermittent errors 25580 and 25581 replicating the reported event.The complaint was confirmed based on the failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to electrical issues from the rac drive module (rdm) board located within the rac-10.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 22101204
• Report Number: 2955842-2025-22650
• Device Sequence Number: 7487287
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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: Male