MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; PATIENT SIDE CART

Model Number	380601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Post Operative Wound Infection (2446)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A review of an article that evaluated the safety and perioperative outcomes of robotic-assisted single-port versus multi-port surgical staging for apparent early-stage endometrial cancer was performed.The retrospective, propensity-matched study analyzed 100 patients undergoing robotic-assisted hysterectomy with bilateral salpingo-oophorectomy and nodal staging using the da vinci surgical system between january 2021 and december 2024.A total of 3 patients in the single-port group experienced postoperative complications within 30 days, including surgical site infection and abdominal pain requiring readmission, and hemoperitoneum requiring surgical re-intervention.No device malfunctions were reported, and the authors did not report any events caused by any intuitive surgical, inc.(isi) device.Multiple attempts were made to contact the author.No response has been received.
Additional Manufacturer Narrative
No investigation could be performed as the article did not provide any specific information regarding the procedure date or da vinci system identifiers.Images associated with this reported event were included in the article.Citation: giannini a, vizza e, bruno v, et al.Robotic-assisted single-port and multi-port surgical staging in early-stage endometrial cancer: a propensity-matched comparison.Eur j surg oncol.2025;51(9):110269.Doi:10.1016/j.Ejso.2025.06.697 section a2: patient information age - reflects the study mean age of the patients in the robotic group.Section a3a: patient gender represents the majority of the patients in the robotic group.Section b7: medical history reflects the study population co-morbidities, not the specific patient.Section d: generic da vinci xi system product information number is provided.Section e: the event site is recorded based on the location of the first author's associated hospital.While the exact site is unknown, this designation is considered an appropriate substitution.Section e: since this article was identified during a literature review by intuitive surgical, inc.(isi) rather than reported by the site, the corresponding author is designated as the initial reporter of the event.

• Brand Name: DA VINCI SP
• 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: 25322546
• Report Number: 2955842-2026-25983
• Device Sequence Number: 9661785
• Product Code: NAY
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 380601
• Device Catalogue Number: 380601
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female