MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; SURGEON SIDE CONSOLE

Model Number	380940-33
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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.Fse replaced the armrest/high resolution stereo viewer (hrsv) limit switch to resolve the issue.The system was tested and verified as ready for use.The affected part involved with this complaint is a field scrap item and will not be returned to isi for further investigation.
Event or Problem Description
It was reported that the system had a faulty limit switch.The actuator in the column was moving when the high-resolution stereo viewer (hrsv) hit its limit and there was also a screeching sound.The values for the armrest were not moving and the limit switch was "open" even when the armrest was at the lowest position, indicating a bad limit switch.There were no reports of patient involvement.

• Brand Name: DA VINCI SP
• Common Device Name: SURGEON SIDE CONSOLE
• 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: 24710163
• Report Number: 2955842-2026-19161
• Device Sequence Number: 12283854
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 380940-33
• Device Catalogue Number: 380940
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2019
• 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