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

Model Number	380620-43
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in a study underwent a da vinci assisted sacrocervicopexy with salpingectomy and cystocele repair procedure.Two weeks later, after discharge, the patient developed dysuria and was evaluated by her outpatient gynecologist.Urinalysis confirmed cystitis.Treatment consisted of fosfomycin 3g, a single dose, resulting in improvement of the symptoms.There were no further medical interventions and the event was reported as resolved the next day.There was no report of intra-procedure complications, da vinci device malfunctions or post-procedure complications prior to discharge after the index surgical procedure.The study investigator reported the event as mild severity, not a serious adverse event, a clavien-dindo grade ii, possibly related to the study procedure, possibly related to the patient's underlying disease status, but not related to the da vinci investigational device, and not related to a third-party device.The patient's prior health conditions of diabetes and surgery may be relevant to this incident.
Additional Manufacturer Narrative
There was no report that a da vinci system, instrument or accessory malfunctioned during the procedure.Additional patient information: height 162 cm., body mass index (bmi) 28.2 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: 50229725
• Report Number: 2955842-2026-35242
• Device Sequence Number: 18710489
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/12/2026

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: 380620-43
• Device Catalogue Number: 380620
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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: 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: 66 YR
• Patient Sex: Female
• Patient Weight: 162 LB