MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; CURVED BIPOLAR DISSECTOR

Model Number	471344-19
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted right pulmonary lobectomy and pulmonary segmentectomy with mediastinal mass resection procedure, bleeding was noted near the root of the superior pulmonary vein, prompting conversion to open thoracotomy.The bronchus was transected using a sureform 45 curved-tip stapler instrument with a sureform 45 black reload.Approximately 15¿20 minutes later, bleeding from the bronchial artery was observed.The surgeon reported that the bleeding was associated with an unspecified technique performed while using the curved bipolar dissector instrument.A da vinci system, instrument, or accessory did not cause or contribute to the reported event.Hemostasis was successfully achieved using a gauze bandage and compression using robotic instruments and the assistant¿s forceps.The estimated blood loss was not provided; however, the patient did not require a blood transfusion.As a precaution, the proctor elected to convert to a small thoracotomy via anterior port #4.The procedure was completed without further complications and a delay of greater than 30 minutes.The patient had no postoperative complications, there are no concerns for long-term sequelae, and the patient has been discharged.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the curved bipolar dissector instrument to perform failure analysis.A review of the stapler log shows that sureform 45 curved-tip stapler instrument (lot number: k12250828-0103), was installed on the system 3 times and fired 3 stapler reloads (2 white, followed by 1 black).On each install, all clamps were successful, and the firings were each completed with no pauses for compression.There were no stapler related errors in the system logs.

• Brand Name: EndoWrist
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 50055990
• Report Number: 2955842-2026-33148
• Device Sequence Number: 21491604
• Product Code: NAY
• UDI-Device Identifier: 00886874121511
• UDI-Public: (01)00886874121511(11)241205(10)K10241205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K214095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 471344-19
• Device Catalogue Number: 471344
• Device Lot Number: K10241205 0064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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: Initial
• 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 Sex: Unknown