MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	488530-13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 30 stapler and stapler 30 white reload with an alleged issue to perform failure analysis.However, failure analysis is not complete.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, since the forceps were not opening and closing at the beginning, it was not possible to open and close properly when actually trying to use them.The procedure was completing as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 30 stapler and sureform 30 white reload with an alleged issue to perform failure analysis.The stapler was installed with an in-house white reload and engaged the instrument onto the in-house system with no issue.The instrument passed initialization, and intuitive motion tests during tests.The instrument open and close with no issue.The instrument successfully clamped and fired the in-house reload.No issue during the process of unclamping, however, during the first firing attempt using an in-house white reload, a staple was not successfully deployed.Performed a second firing with in-house gray reload and all staples were deployed successfully.The instrument was found to have functional test firing failure based the customer¿s logs.The logs showed a firing failure ¿tissue too thick¿ on one occasion causing an auto detection failure.The instrument came with a white reload and visual inspection showed the white reload had a broken switch.Removed the white reload from the field, installed an in-house white reload (with no issue) then onto an in-house system and fired on a test sheet.The instrument fired successfully, and the resultant staple-line was visually inspected.The cutline appeared inconsistent, with one staple unsuccessfully fired.Please refer to the report with mfr report number 2955842-2026-02515 for the complete investigation of the sureform 30 white reload.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Initial findings were partially confirmed by engineering.The reload was returned with a stapler instrument that experienced a firing failure with a white reload.The firing was completed to ~28% and the instrument was not used again.During install, the graphical interface (gui) was used to manually select the reload color.The driver of the instrument exhibited significant damage to the cutting edge, indicating interaction with something hard.Additional findings with the instrument were witness marks on the lockout cover that indicate switch interaction.Review of the returned reload aligns with the completion percentage in the logs.The reload appears partially fired with proximal staples deployed.The reload was found to have a broken tail, cartridge damage to the tail where the switch is held, a crack in the cartridge body, and a fragment from a broken switch still lodged in the tail.The tail was still full attached to the cartridge body but exhibited a fracture point.The switch fragment was removed and measures 1.02mm x 3.73mm.The remaining switch fragment or fragments were not found with the reload and were not returned.No fragments were found within the stapler jaws.Based on the significant damage to the cartridge tail, switch component and driver of the instrument used during the firing failure, it is likely that the switch component of the reload was misaligned within the channel during reload installation.The reload was seated with a misaligned switch, causing damage to the tail of the cartridge, but defeating the lockout mechanism enough to initiate the fire.With the switch misaligned, it is likely that during the fire, the driver rammed into the switch component, resulting in fracture of the switch and firing forces to spike.With the increased firing forces, the firing threshold was reached and the system halted the firing.Proper use of the installation tool will ensure the reload tail and switch are align within the channel during seating, preventing damage to the instrument and reload.Initial findings were partially confirmed.The procedure logs were reviewed and confirm the instrument experienced a tissue too thick to continue firing failure on the only install in the field.The firing failure occurred with a white reload.Firing was tested in-house with the returned instrument and fully deployed all staples, however the cut line was jagged.Although primary failure analysis coded the firing failure as replicated, a partial fire was not replicated during testing.The cut-line during testing is jagged due to the damage found on the knife.The instrument jaws were disassembled.Witness marks were observed on the lockout cover, which can indicate reload installation difficulties.The witness marks are likely caused by interaction with the switch component of a reload.No loose or lodged components were found during disassembly.The lockout mechanism could be defeated manually and sprung back into the channel upon release.The driver knife cutting edge was inspected and found with significant mechanical deformation.The deformation to the cutting edge is the likely cause of the jagged cut line observed during testing.As no lodged components, such as the switch, were observed within the instrument, the root cause of the partial fire can be determined.The root cause of the damage to the driver cutting edge is related to firing across hard objects.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 24035848
• Report Number: 2955842-2026-00484
• Device Sequence Number: 10472811
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)U10250123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• 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,Followup,Followup
• Report Date (Section B): 03/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 488530-13
• Device Catalogue Number: 488530
• Device Lot Number: U10250123 0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/09/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/29/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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