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

Model Number	380730-45
Medical Device Problem Code	Positioning Problem (3009)
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 instrument installed in universal surgical manipulator (usm)1 would not open without manual assistance from another instrument.A system restart was attempted by the staff, during which a boom disabled message was displayed.Error 31089 was identified, pointing to the upper right blue fiber port.It was recommended that the fiber cable from the patient side cart (psc) be swapped to a new port.The cable was swapped and the system was restarted, powering up normally however, the instrument in universal surgical manipulator (usm)1 still could not be opened.It was then recommended that control be taken from the second surgeon side console (ssc).Upon moving to the alternate console, the usm1 instrument was opened without issue, and the staff proceeded using usm2 as the active console.The procedure was completing as planned with no reported injury.
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.The failure analysis confirmed and replicated the reported complaint.A review of complaint mentioned unit grips were springing back out when surgeon attempted to grip.A visual inspection was performed and found the mtm to have a defective grip spring in which it was deformed and damaged.Confirming issue infield.The mtm was placed on surgeon console fixture test platform (sftp) to perform fitness tests and 1 hour sine cycle.A gold grip spring was installed prior to sftp placement.The mtm passed most of the fitness tests except for the gravity balance test post sine cycle oy failed the following specs yaw max friction, yaw min margin gravity sequence and re tensioning were performed, re executed test, and failure persisted.Aba swapped cables on axis 1, continued to fail.Installed original cables and aba swapped capstan and passed.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.

• 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: 50910832
• Report Number: 2955842-2026-40137
• Device Sequence Number: 5777947
• Product Code: NAY
• UDI-Device Identifier: 00886874119747
• UDI-Public: (01)00886874119747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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: 380730-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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