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

Model Number	380601-51
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse found no related errors in the log.The fse made mechanical and electrical adjustments to correct the reported event.Fse completed the shoulder calibration, self-test with same parameters such as positioning and using manipulator on surgeon console.The system was tested and verified as ready for use.The complaint was confirmed based on the field evaluation.Isi received a video clip related to the alleged complaint.A review of the video clip was conducted by the fse.The following additional information was provided: the video showed an issue with shoulder brake.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure with single-port (sp) da vinci system, the customer informed intuitive surgical, inc.(isi) technical support engineer (tse) that patient side cart (psc) boom was not stable in the x-axis.The tse could not find any related error in the logs.The tse advised the customer to power cycle.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the issue was not resolved during the procedure.The boom was still moving when the customer tried to move it without pressing any clutch or force.The issue caused uncontrolled motion of the instrument when the customer touched the body of the robot to change an instrument or clean up the endoscope.The issue did not affect the procedure, and the procedure was completed robotically.

• 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: 25085903
• Report Number: 2955842-2026-23844
• Device Sequence Number: 10533029
• Product Code: NAY
• UDI-Device Identifier: 00886874114605
• UDI-Public: (01)00886874114605
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 05/05/2026

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: 380601-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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