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

Model Number	380723-12
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer, an investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse went on-site and replaced the left master tool manipulator (mtm).The system was verified and ready for use.Isi has not received the mtm for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.The probable root cause is attributed to component failure based on electrical and fiberoptic defects.
Event or Problem Description
It was reported that during a da vinci-assisted endometriosis resection and hysterectomy benign surgical procedure, that the customer contacted the technical service engineer (tse) to report noise coming from the master tool manipulator left (mtml).The customer had restarted the da vinci system, but the reported complaint persisted.To complete the surgery, the customer used a surgeon side console from another da vinci system.Live logs reviewed at that time did not show any errors related to the noise, and an onsite visit was requested prior to the next surgery.It was later reported that the onsite engineer informed tse that the case associated with this issue had been converted to a laparoscopic procedure in the final stages.It was subsequently reported that the customer called during a later procedure to report ongoing noise from the mtml.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: during the surgical procedure, an intermittent issue was observed with the master tool manipulator left, which did not enter a completely non-functional state but exhibited irregular performance.As a result of this, and because the facility was equipped with two da vinci surgical systems, the surgical team utilized another system (ssc) to successfully complete the procedure.Additionally, the issue was reported specifically during the suturing phase, prompting the surgeon to promptly convert to laparoscopic surgery to ensure patient safety and procedural continuity.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The master tool manipulator (mtm) was analyzed, and it could not be replicated during testing on surgeon side console fixture test platform (sftp).No visual defects related to the reported issue were identified during inspection.

• 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: 24949144
• Report Number: 2955842-2026-22413
• Device Sequence Number: 5280309
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 380723-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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: Female