MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE

Model Number	380610-17
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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.The fse confirmed that issue was resolved after few minutes.The system was verified and ready to use.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer indicated that the left master tool manipulator (mtml) was drifting and not working properly.The procedure was converted to another dv with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer indicated that the issue was resolved automatically after 3-5 mins.The instrument was in patient at the time of the event.The motion issue due to mtm drift did not occur when surgeon removed hands from mtm while head still in viewer.No known impact or patient consequence was reported.

• Brand Name: DAVINCI SI
• 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: 22046613
• Report Number: 2955842-2025-20866
• Device Sequence Number: 8880778
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

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: 380610-17
• 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: 04/28/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2014
• 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: Reuse
• 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