MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number	380990-16
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the set-up joint (suj3) had limited range of motion.Customer stated that axis 5 was hard to move and they could hear noise while moving it.No errors were reported on the system.Customer continued with the procedure without patient side manipulator (psm3).The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
An intuitive surgical inc., (isi) field service engineer (fse) was dispatched to the site to further investigate the reported event.Fse inspected the system and noted that set-up joint was defective and motion on axis 5 was limited.Fse replaced the set-up joint (sjx) to resolve the reported issue.The system was tested and verified as ready for use.The sjx involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the set-up joint (sjx) involved with this complaint to perform failure analysis.The sjx unit was analyzed and after visually inspecting the unit, the issue with axis 5 being stuck was replicated.The complaint was confirmed based on the failure analysis.The probable root cause is attributed to a the faulty sjx axis 5 brake clamp, stop block and bumpers.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM
• 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: 23987078
• Report Number: 2955842-2026-00439
• Device Sequence Number: 17287796
• Product Code: NAY
• UDI-Device Identifier: 00886874110874
• UDI-Public: (01)00886874110874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 380990-16
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2017
• 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: Unknown