MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD GREEN

Model Number	48360G-10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the sureform 60 stapler instrument was inserted inside the body cavity for transection, but it failed to operate and was unusable.Both the stapler instrument and the reload were replaced.The procedure was completed with no reported patient injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform stapler 60 instrument to perform failure analysis.The instrument was analyzed and the complaint was not confirmed by failure analysis.Visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully using a white 60 reload.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.Review of logs were unable to verify any failures.The instrument was fully functional.There was no problem detected.Isi also received the sureform 60 green reload to perform failure analysis.Failure analysis investigation replicated and confirmed the customer-reported complaint.The reload was found with three staples lodged in front of the knife stopping point, wedged between the reload and the exposed knife, which caused jamming.A visual inspection also identified cartridge and mechanical damage to the knife blade, including indentations.A fragment of the damaged cartridge was found lodged ahead of the knife and removed.Log review confirmed that the reload was not involved in a firing failure.The knife was exposed toward the distal end of the reload, and an inspection after removing the reload cover and advancing the shuttle confirmed blade damage.The reload was returned attached to instrument.The complaint was confirmed by failure analysis.The probable root cause of lodged staples is attributed to user-related factors, including device use and sample handling.A blade exposed icon and message will appear if the firing sequence is interrupted.The probable root cause of the exposed component can be attributed to various factors.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.The probable root cause of cartridge damage and blade damage is attributed to high firing torques, which can result from firing on challenging tissue (e.G., tissue condition) or hard objects (e.G., staples).

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 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: 23871657
• Report Number: 2955842-2025-49490
• Device Sequence Number: 17294500
• Product Code: GDW
• UDI-Device Identifier: 10886874113841
• UDI-Public: (01)10886874113841(17)280331(10)K11250320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• 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: 48360G-10
• Device Catalogue Number: 48360G
• Device Lot Number: K11250320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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
• Patient Sex: Unknown