MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI 5; PATIENT SIDE CART

Model Number	380747-40
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was addressed with phone support.The field service engineer (fse) contacted the robotics coordinator, who informed that the system had been functioning without concern and that the usm 3 felt normal.There were no further concerns and the site was continuing with cases.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, the surgeon reported universal surgical manipulator (usm) 3 felt like it was working against the surgeon¿s movement.The staff had undocked the robot to reposition and the issue had appeared to be resolved.Shortly thereafter, the surgeon explained the usms appeared to be moving backwards.The surgeon requested the field service engineer (fse) to follow up to verify the system and the intuitive motion of the system.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: they realized that the surgeon was working in the lower abdomen with the system orientation set for the upper abdomen.They believed this may have cause the reversed motion issue.The procedure was completed as planned without any injury or harm to the patient.

• Brand Name: DAVINCI 5
• Common Device Name: PATIENT 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 ; 4085232100
• MDR Report Key: 21905189
• Report Number: 2955842-2025-16774
• Device Sequence Number: 19013543
• Product Code: NAY
• UDI-Device Identifier: 00886874119716
• UDI-Public: (01)00886874119716
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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: 380747-40
• 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: 04/16/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2024
• 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: 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
• Patient Sex: Unknown