MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number	380723-19
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure that the right master tool manipulator (mtm) dropped on its own.The intuitive tech support engineer (tse) reviewed the system logs and found error 23075, indicating the right mtm drifted.The suspect mtm was controlling universal surgical manipulator (usm) 3, which had a large needle driver instrument installed.The instruments were swapped between usms 1 and 3 and the issue remained.There were no reports of patient injury.Intuitive received the following additional information via follow up: the customer was able to continue the procedure robotically, experiencing difficulty with the right mtm.The doctor could feel the effect of this issue on their own wrist.The customer completed the procedure using all 4 usms.There was a surgical delay of 15-20 minutes.The mtmr was replaced.Everything was working properly.
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).The system was tested and verified as ready for use.Isi has not received the da vinci product with an alleged issue to perform failure analysis.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

• Brand Name: DA VINCI XI
• Common Device Name: SURGEON SIDE CONSOLE, RECONDITIONED
• 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: 24865428
• Report Number: 2955842-2026-21333
• Device Sequence Number: 18483630
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 380723-19
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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