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

Model Number	380614-12
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Great Vessel Perforation (2152)
Date of Event	09/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
No specific information regarding the procedure date was provided; therefore, no da vinci system or accessories log files or device history record are available.The manufacturer of the suture product was not provided.A review of the event performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report was undergoing a partial nephrectomy when the renal artery was damaged.How it was damaged was not provided.An attempt at repair failed and the patient eventually bled from this again, underwent additional procedures including a completion nephrectomy, but ultimately expired.There is no allegation against any intuitive surgical product or instrument and the hospital determined there were surgical technique issues that led to the bleed.Based on the information provided in the summary of events, no intuitive surgical product or instrument contributed to this event.Section b3 event date: only the month and year were provided ((b)(6) 2022) thus the event date is estimated as (b)(6) 2022, and the b2 date of death is estimated as (b)(6) 2022 per report of death one day post-procedure.
Event or Problem Description
It was reported that during a da vinci assisted partial nephrectomy for tumor removal, the patient¿s renal artery was damaged; although the artery was repaired, post-operative bleeding occurred and the patient expired.The source of the information was from unspecified media coverage of the event.The unconfirmed source data reported that the bleeding vessel was sutured, but the suture thread broke, resulting in fewer ligations (2-3 times) than normal.Additional sutures were performed after the breakage, but the hemostasis was still insufficient which led to post-operative bleeding.The patient¿s post-operative condition worsened.The patient received additional interventions, including kidney removal and blood transfusions.The patient expired from hemorrhagic shock on post-operative day one.The source of the information was from unspecified media coverage of the event.The hospital reports that they investigated the event and concluded the cause of death was re-bleeding as a result of loosening of the sutures at the hemostasis site.The hospital plans to implement a system where multiple physicians confirm hemostasis.No additional information was provided.

• 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: 25713093
• Report Number: 2955842-2026-30475
• Device Sequence Number: 10644318
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/05/2026

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: 380614-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2014
• 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: Death; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male