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

Model Number	380730-40
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
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 system was displaying a message instructing the user to shut down.The logs were reviewed and the issue was confirmed.Troubleshooting determined that the right arm on the console was causing the problem, as it was not recognized by the console.The procedure was converted to another dv system.
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) right 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.During the investigation, failure analysis reviewed the field logs and the reported errors were confirmed in the field logs but could not be replicated during in house testing, indicating an intermittent failure.The mtm was subsequently installed on surgeon console fixture test platform (sftp) for further evaluation.During testing, the unit initially failed the following test grip accuracy test post sine cycle failed the following specs calib rom delta.A recalibration sequence was performed, after which the unit passed all previously failed tests.A one hour sine cycle test was subsequently performed, and the unit passed successfully without any issues.An additional finding was identified during fitness testing that was not related to the field complaint slow gravity balance test post sine cycle wp failed the following specs wrist pitch ripple trq max power bevel teeth fwd drive, slow gravity balance test post sine cycle wy failed the following specs wrist yaw ripple rq max power bevel teeth fwd drive.A visual inspection was performed.Failure analysis noted that one of the pivot covers was damaged, one screw on the grip housing was missing, and the unit had an older revision of the axis 1 cover.No other external mechanical damage, contamination, or abnormal conditions related to the reported event were observed.Based on the investigation and evaluation results, failure analysis determined that the slipring was the root cause of the reported event.

• 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: 50850343
• Report Number: 2955842-2026-39642
• Device Sequence Number: 9508404
• Product Code: NAY
• UDI-Device Identifier: 00886874119747
• UDI-Public: (01)00886874119747
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/21/2026

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: 380730-40
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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: ISIFA2024-07-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Patient Sex: Unknown