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	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted inguinal hernia surgical procedure, the customer had recoverable fault on the patient side manipulator (psm) 3.The customer reported that before docking the system displayed the errors 10025, 25553, 31004 recoverable faults and the non-recoverable fault 252.The customer restarted the system and disabled the psm3 and start the docking with just two arms.The system presented the errors on startup.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the reporter and obtained the following additional information: the ports were placed prior to issue being identified.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was confirmed.The errors 25554, 25553 related to the remote arm controller (rac) board and the errors 23016, 23004 related to the patient side manipulator (psm).The fse replaced the psm and rac to resolve the issue.The system was tested and verified as ready for use.Isi has not received the da vinci products with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/or if additional information is received.
Additional Manufacturer Narrative
The remote arm controller (rac) board has been returned and evaluated by the failure analysis (fa) team.The unit was returned for fa, but the reported failure could not be reproduced.The rac was installed onto surgeon side console test system.It started up with no problems or errors and continued where it ran 10x power cycle and sat idle for one hour.After it was tested on the printed circuit assembly (pca) system and fa was unable to replicate the reported error 25553 and 25593.

• 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: 19218287
• Report Number: 2955842-2024-13972
• Device Sequence Number: 6960751
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/18/2024
• 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