MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci X; PATIENT SIDE CART, 4-ARM

Model Number	380620-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in a study underwent a da vinic assisted pulmonary segmentectomy.Two days later, it was reported that the patient experienced an atrial arrhythmia and was prescribed bisoprolol and enoxaparin as treatment; a cardiologist consult will be performed.The event is reported as ongoing.There were no intra-procedure complications and no da vinci device malfunctions.Discharge occurred four days after surgery without a prolonged hospitalization.The study investigator reported the event as severe, a serious adverse event, a clavien-dindo grade ii, possibly related to the patient's underlying disease status, but not related to the da vinci study device, and not related to the procedure.
Additional Manufacturer Narrative
There was no report that a da vinci system, instrument or accessory malfunctioned during the procedure.Additional patient information: height 175cm., body mass index 24.3 kg/m2.

• Brand Name: daVinci X
• Common Device Name: PATIENT SIDE CART, 4-ARM
• 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: 50114755
• Report Number: 2955842-2026-34127
• Device Sequence Number: 5254171
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2026

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: 380620-33
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/03/2026; 08/17/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/13/2026; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2018
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 132 LB