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

Model Number	48345T-01
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary wedge resection surgical procedure, the sureform 45 stapler instrument misfired while the surgeon was using it.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The sureform 45 black reload was found to have lodged staples wedged in between the reload knife track.Visual inspection confirms there are two lodged staples.The blade had progressed through the full firing trajectory, and the staples were located behind the blade's stopping point, which is a result of a force fire.There was minor blade damage to the knife, and minor cartridge damage caused in-house during staple removal.The blade was not expose upon receipt due to the force fire confirmed in the logs.The reload blade was found to have mechanical indentations.The reload cover was removed to allow access to the knife.Visual inspection found minor damage to the blade.There was no cartridge damage observed upon receipt.The cartridge was damaged in-house when attempting to remove the staples.The probable root cause of the firing failure can be attributed to various factors.A blade exposed icon and message will appear if the firing sequence is interrupted.These factors may include instrument damage, particularly in the wrist area, tissue condition (e.G., disease state and density), and foreign objects (e.G., metal clips) that can cause stapler firing forces to exceed the prescribed limit and subsequently result in a partial fire.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLACK
• 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: 23870332
• Report Number: 2955842-2025-49027
• Device Sequence Number: 17475194
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345T-01
• Device Catalogue Number: 48345T
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2019
• 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
• Patient Sex: Unknown