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

Model Number	380686-04
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
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 confirmed that the sterile adapter and instruments were no recognizing properly on the patient side manipulator (psm).The fse tried reseating sterile adapters and instruments with no resolve.Fse replaced the psm to resolve the issue.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis (fa).The psm was analyzed and the reported issue was able to be reproduced upon installing the unit on a golden system and performing get switches test.As a result, fa was able to determine that the link 6 spring plungers and link 6 front cover was found to be the root cause of the reported problem.The complaint was confirmed based on the results of the investigation, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that prior to starting ¿ pre anesthesia of a da vinci-assisted simple prostatectomy surgical procedure, the customer contacted the technical support engineer (tse) and reported sterile adapter is not detecting on arm 3.The site was proceeding the surgery by abandoning the arm 3.The site tried changing the drape.The tse suggested the customer clean the pogo pins on the arm 3 and try again.The customer informed they would do the check after the procedure completion.The system was not connected to onsite during time of call.The customer called back and confirmed the issue is not resolved by the troubleshooting recommended.The procedure was completing as planned with no reported injury.

• 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: 24710146
• Report Number: 2955842-2026-19205
• Device Sequence Number: 14979983
• 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
• Report Date (Section B): 03/26/2026

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
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 03/30/2026
• 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: Initial
• 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