MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci 5; Surgeon Side Cart

Model Number	380730-50
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the customer contacted the technical support engineer (tse) and reported that the left hand controller clutch was not functioning correctly.A system message was displayed indicating that the clutch on the hand control was unavailable and that the foot pedal should be used as a workaround.Upon reviewing the system logs, error 23152 was identified, which indicated that the master tool manipulator (mtm)clutch button hall effect sensor was operating outside the safety envelope limit.The procedure was completing as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
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 replaced the master tool manipulator (mtm) to correct the issue.The system was tested and verified as ready for use.Isi did receive the product involved with this complaint and performed the failure analysis.This mtm was analyzed and the reported complaint of master controller error was confirmed, but was not replicated during in house testing.In lighthouse, the errors 23152 ,23007 on grip axis were found, confirming the fault occurred in the field.Upon visual inspection, no issues were found that would be related to the reported event.The mtm was installed on an in house system and driven with an in house instrument.No issues were observed and the unit passed system test.No issues with the clutch buttons were observed.After installing on surgeon console fixture test platform (sftp) and running the fitness test, the mtm failed verify encoder cal wp, wy, ro and grip, gravity balance test post sine cycle sh(max imbalance), el (min margin, max imbalance).After running calibrations, the mentioned tests passed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the patient details were provided.

• Brand Name: daVinci 5
• Common Device Name: Surgeon 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 ; +1(408)523-2100
• MDR Report Key: 50910836
• Report Number: 2955842-2026-40142
• Device Sequence Number: 5777950
• Product Code: NAY
• UDI-Device Identifier: 00886874119747
• UDI-Public: (01)00886874119747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• 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,Followup
• Report Date (Section B): 09/30/2026

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: 380730-50
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2026
• 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 Age: 52 YR
• Patient Sex: Unknown
• Patient Weight: 171 LB