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

Model Number	380614-15
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Unspecified Tissue Injury (4559)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
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.Citation: zhao, l., et.Al.(2025).Surgical outcomes of robotic hysterectomy for large uterus weighing more than 1000g: a retrospective study from a high-volume center.Journal of robotic surgery, 19, 253.Https://doi.Org/10.1007/s11701-025-02422-1.Section a2: patient information age: reflects the study mean age of the patients.Section b7: the patient's medical history is updated per the majority of the patient's characteristics.Section d: due to the lack of specific information regarding the da vinci system associated with the adverse event, a generic system material number was used.Section e: since this article was identified during a literature review by isi, rather than reported by the site, the corresponding author is designated as the initial reporter of the event.
Event or Problem Description
A review of an article that investigated the impact of various risk factors on surgical outcomes and to identify the most effective surgical approach for performing robotic hysterectomy (rh) was performed.The article describes a few non-specific intra-operative complications with minimal details.A total of 4 incidents of organ injuries were recorded.One patient experienced a bladder injury, and three patients experienced vaginal lacerations, all of which required intraoperative repair without subsequent complications.Additionally, 6 cases necessitated intraoperative blood transfusions.Post-operatively, one patient suffered a cuff infection and urinary tract infection requiring antibiotic therapy, and another patient experienced cuff dehiscence and bleeding leading to readmission and resolution after secondary suture, and one patient experienced urinary retention requiring catheterization for 2 weeks.Eleven cases required postoperative blood transfusions.There were no specific da vinci device malfunctions reported, and no indication that intuitive surgical, inc.(isi) products caused or contributed to any adverse event.Isi made follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
This record was identified as a duplicate of another submitted mdr with manufacturer report number 2955842-2026-04833.No additional information will be submitted under this report.
Additional Manufacturer Narrative
The same event has been submitted under mfr #2955842-2026-04833.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• 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 ; 4085232100
• MDR Report Key: 24329497
• Report Number: 2955842-2026-03997
• Device Sequence Number: 5018733
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 380614-15
• Device Catalogue Number: N/A
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/06/2026; 05/07/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/31/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2016
• 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; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female