MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; STAPLER 30 RELOAD WHITE

Model Number	48630W-06
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/14/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy, the patient experienced bleeding and despite subsequent control of the bleeding, the patient developed asystole and expired.During the procedure, a right upper lobe tumor was identified.The superior pulmonary vein was isolated while preserving the middle pulmonary vein and boyden arterial trunk.The pulmonary vessels were dissected and divided using a curved tip endowrist 30 stapler with a white reload, as confirmed by system logs.Approximately one hour later, during dissection of the pulmonary ligament, a sudden massive hemorrhage occurred in the hilar region.The procedure was emergently converted to an open thoracotomy.The bleeding source was identified as the previously stapled pulmonary artery stump.Hemorrhage control measures, including hilar clamping, blood salvage, and resuscitative efforts, were performed, however, the patient expired intraoperatively.
Additional Manufacturer Narrative
The following concomitant products were used during this procedure: 30-degree endoscope plus, tip-up fenestrated grasper, cadiere forceps, permanent cautery spatula, fenestrated bipolar forceps, endowrist 30 curved-tip stapler, sureform 45 curved-tip stapler.A site review found that no complaints have been reported for any of the products used.A review of the site's system logs for the reported procedure date was conducted.This investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.Stapler logs showed the endowrist 30 stapler instrument used in this procedure was installed 3 times and fired 3 white reloads.On the first install, homing was completed, and the clamping, firing, unclamping sequence was completed.On the second install, logs show an error code indicating no reload was detected on universal surgical manipulator (usm) arm 2.Following the manual reload color selection, homing passed and clamping, firing, unclamping sequence was completed.On the third install, homing passed, and clamping, firing, unclamping sequence was completed per the logs.After the third firing, the endowrist stapler 30 curved tip was replaced by a sureform 45 curved-tip stapler instrument and fired one green reload with no issues clamping, firing or unclamping.A review of the event performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report died during a pulmonary lobectomy when a staple line created by a endowrist 30 mm stapler with a white reload bled about an hour after the stapling had been implemented.The bleeding started when the pulmonary ligament was being manipulated.How this maneuver and traction placed on the staple line and vessel may have contributed to the cause of bleeding is not clarified.The patient bled from the artery and eventually died.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive product contributed to this event.

• Brand Name: EndoWrist
• Common Device Name: STAPLER 30 RELOAD WHITE
• 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: 50235259
• Report Number: 2955842-2026-35681
• Device Sequence Number: 13326272
• Product Code: GDW
• UDI-Device Identifier: 10886874112868
• UDI-Public: (01)10886874112868(17)280630(10)K10250701
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K152421
• 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): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 48630W-06
• Device Catalogue Number: 48630W
• Device Lot Number: K10250701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Death; Required Intervention
• Patient Sex: Unknown