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
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 45 stapler instrument was found to have four firing failures based on log review which were not replicated through in-house testing.The stapler was installed onto an in-house system and fired on a test foam using two in-house black reloads.One of the firing tests was a high challenge foam test.The instrument fired successfully, and the resultant staple-line was visually inspected.The cut-line appeared smooth and consistent, with jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.Review of logs confirmed four firing failures, and two forced fires.Visual inspection confirms there are two lodged staples in the reload.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 forced fire.There was minor blade damage to the knife.No cartridge damage was found.The blade was not exposed 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 damage to the blade.There was no cartridge damage observed.The second reload was found to have the knife exposed within the knife track.Log review confirms the reload was involved in a firing failure.The knife was exposed towards the middle of the returned reload, which aligns with the firing completion percentage displayed in the procedure logs.The reload blade was found to have mechanical indentations.The reload cover was removed, and the shuttle was pulled forward to allow access the knife.Visual inspection found damage to the blade.There was no cartridge damage observed.The third reload was found to have the knife exposed within the knife track.Log review confirms the reload was involved in a firing failure.The knife was exposed towards the middle of the returned reload, which aligns with the firing completion percentage displayed in the procedure logs.The fourth 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.
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.

• 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: 23856941
• Report Number: 2955842-2025-48800
• Device Sequence Number: 15981815
• Product Code: GDW
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)NA
• 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): 12/19/2025

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
• 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: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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