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

Model Number	380610-20
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
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 inspected the system and observed that a cable behind left master tool manipulator (mtm-l) was giving resistance to user.As a result of this resistance, mtm-l initiation failed during system start-up.The cable was removed to resolve the issue.The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the left master tool manipulator (mtm-l) on surgeon side console (ssc) could not be moved.The system did not represent any errors.An intuitive surgical inc., (isi) technical support engineer (tse) guided customer to perform a hard power cycle on system but issue remained unresolved.There were no reports of patient injury.The procedure was converted to laparoscopy with no reported injury.An isi field service engineer (fse) to follow-up.Intuitive surgical inc., (isi) followed up with the initial reporter and obtained the following additional information: customer tried to perform a hard power cycle on the system but mtm-l would not function normally.The conversion did not result in placement of additional ports.The port size incision was not increased.There was no patient injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The probable root cause is due to an obstruction from the cable blocking the mtm.

• 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: 22379930
• Report Number: 2955842-2025-28470
• Device Sequence Number: 8300849
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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: 380610-20
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2015
• 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