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 Codes	Abdominal Pain (1685); Hematoma (1884); Unspecified Infection (1930)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient in a study underwent a da vinci assisted cervixexstirpation with concomitant douglasplastik surgical procedure.Twenty days after surgery, the patient complained of lower abdominal pain and subsequently presented to an outpatient gynecologist.A hematoma was diagnosed, for which a one-week course of antibiotics and analgesics was initiated.The symptoms improved significantly with this treatment.Currently, the patient is largely asymptomatic, with only mild spotting persisting.A follow-up gynecological examination is still pending; the event is reported as ongoing.The surgical procedure was completed with no intra-operative complications or da vinci device malfunctions.There were no post-operative complications prior to discharge which occurred the day after surgery.The study investigator reported the event as mild severity, not a serious adverse event, a clavien-dindo grade ii, having a causal relationship to the study procedure, but not related to the da vinci investigational device, not related to the patient's underlying disease status, and not related to a third-party device.
Additional Manufacturer Narrative
There was no report that a da vinci system, instrument or accessory malfunctioned during the procedure.

• 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: 50852849
• Report Number: 2955842-2026-39623
• Device Sequence Number: 18554666
• 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): 09/22/2026

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: 46 YR
• Patient Sex: Female