MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci SP; SURGEON SIDE CONSOLE

Model Number	380940-55
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to starting a da vinci-assisted procedure, post-anesthesia and after port placement, the customer reported the foot tray did not lower when the brake was pressed.Multiple system power cycles were attempted, but the issue persisted.While troubleshooting was ongoing, the surgeon elected to convert the case to laparoscopic surgery.An obstacle was then identified underneath the foot tray; once the obstruction was removed, the foot tray function returned to normal.The laparoscopic procedure was completed without further issue.The customer stated ports had already been placed, and docking and instrument installation were completed before the issue was identified.The procedure was converted to a laparoscopic approach because the surgery had been delayed due to the weekend schedule and there was pressure from the anesthesia team to proceed efficiently.Following conversion, one additional port was placed in addition to the existing ports.The surgeon had informed the patient preoperatively that conversion to video-assisted thoracoscopic surgery (vats) might be necessary, as this was the surgeon¿s first case with the single port (sp) system, and the patient tolerated the conversion without any reported issues.No patient injury occurred, and the surgeon did not report any postoperative concerns; based on available information, the patient is expected to be doing well without known complications.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.During troubleshooting, an obstacle was identified underneath the foot tray; once the obstruction was removed, the foot tray function returned to normal.No site visit was required.The system was working properly, and no additional action was required as the issue was resolved.

• Brand Name: da Vinci SP
• Common Device Name: SURGEON SIDE CONSOLE
• 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: 50155556
• Report Number: 2955842-2026-34680
• Device Sequence Number: 10603007
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380940-55
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/11/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• 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: Reuse
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown