MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number	380601-34
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon observed the halo rotated unexpectedly.There were no errors reported on the system and no further information was available.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The field service engineer spoke to robotics coordinator and stated after speaking with the scrub tech and clinical representative that it was not an issue with the robot.They also stated that it worked without error all day today.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.

• Brand Name: DA VINCI SP
• Common Device Name: PATIENT SIDE CART
• 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: 25100893
• Report Number: 2955842-2026-23997
• Device Sequence Number: 10018712
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 380601-34
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2019
• 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