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

Model Number	48345W-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, halfway through the stapling process with a sureform 45 curved-tip stapler instrument and a sureform 45 white reload, an error message appeared to pause for compression.The stapling continued, and before completion, the device jammed and a second message indicating tissue was too thick, stapling impossible appeared.This resulted in a partially severed stump of the pulmonary artery branch.Approximately 120 ml of blood loss occurred.Compression hemostasis, followed by electrical hemostasis and the application of hemostatic agent (i.E.Tachosil) was performed to control the bleeding.This issue caused a delay between 15 and 30 minutes: time required to safely remove the stapler, re-cut the partially severed stump, perform primary hemostasis, and then recheck the staple line.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.The stapler logs showed the sureform 45 curved-tip stapler instrument was installed on the system 9 times and fired 8 sureform 45 reloads (2 white, 5 black, 1 green).On installs 1, 4-6, 8 and 9, the first clamps were successful, and the firings were each completed with no pauses for compression.On install 2, the first clamp was successful but was followed by a firing failure.On install 3, no clamping or firing was attempted.On install 7, the first clamp was incomplete.The next clamp was successful, and the firing was completed with no pauses for compression.There were no stapler related errors in the logs.Concomitant device(s): sureform 45 curved-tip stapler instrument (part #480545-06).

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 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 ; 4085232100
• MDR Report Key: 25492037
• Report Number: 2955842-2026-28413
• Device Sequence Number: 21323570
• Product Code: GDW
• UDI-Device Identifier: 10886874117122
• UDI-Public: (01)10886874117122(17)280930(10)K12250925
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183224
• 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): 06/12/2026

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: 48345W-03
• Device Catalogue Number: 48345W
• Device Lot Number: K12250925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2025
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Unknown