MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD GREEN

Model Number	48345G-02
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sureform 45 instrument has not been received for failure analysis investigation.The customer declined to return the sureform 45 stapler instrument used during this event as it functioned as intended with the other stapler reloads that were fired.The stapler logs for this procedure were reviewed: the logs show a sureform 45 stapler instrument was installed on the system 3 times and fired 3 sureform 45 reloads (1 white, 1 green, 1 black, in that order).There were no relevant stapler related errors in the logs.A review of an image provided by the customer was performed.The image shows that the blade stopped around the third pusher row, with the fourth pusher row just beginning to deploy.This would indicate that the shuttle ramps stopped near this proximal location, rather than at the distal end.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, a sureform 45 stapler instrument fired a sureform 45 green reload which resulted in an incomplete staple line on parenchyma.The staples were deployed and tissue was cut, but it was reported that there were three lines of staples that were not properly placed into the tissue.There was minor bleeding of the parenchyma due to this event which was controlled with energy from a maryland bipolar forceps instrument.The surgical outcome was not affected by this event and the patient outcome was reported to be normal.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GREEN
• 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: 23701032
• Report Number: 2955842-2025-46604
• Device Sequence Number: 21505567
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(17)250831(10)K10230817
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48345G-02
• Device Catalogue Number: 48345G
• Device Lot Number: K10230817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: Required Intervention
• Patient Sex: Unknown