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

Model Number	48345T-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer observed that the sureform 45 stapler instrument was inserted into the arm, tissue was detected, and the system indicated that it was possible to fire the instrument.Halfway through the firing, the system reported that it could no longer proceed and that it was necessary to replace it with a stronger reload.That one could be fired.The issue was that the system incorrectly assessed the tissue thickness.The procedure was completed with no injury.
Additional Manufacturer Narrative
The sureform (sf) 45 stapler instrument was found to have one firing failure based on log review which was not replicated through in-house testing.The instrument was installed onto an in-house system and fired on a test foam using an in-house sf45 white reload.The instrument fired successfully and the resultant staple-line was visually inspected.The cut-line appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.For clarification: the instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The stapler initialized, clamped, fired, and unclamped without any issues with an in-house sf45 white reload.The sf 45 black reload was returned with the stapler instrument.The reload was deployed.According to logs the instrument had three errors indicating tissue being too thick.Additional observation not reported by site: the reload was found to have lodged staples.The deformed lodged staples were found at the knife groove.The sf 45 green and blue reloads were returned with the stapler instrument.The reloads were returned partially deployed.No lodged staples were found.According to logs the stapler instrument had three errors indicating tissue being too thick.The probable root cause of the customer reported issue on sureform 45 stapler, sureform 45 reload black, sureform 45 green and sureform 45 blue cannot be determined based on the information provided and failure analysis results.No product issue was identified.The reported event was not confirmed as failure analysis found the instruments worked without any issue.The instrument was visually inspected and evaluated for its mechanical and/or electrical characteristics.The failure analysis investigations and in-house testing of the returned product revealed no issues related to the customer reported event.The probable root cause of the lodged staple is attributed to the user issue as per the failure analysis.

• 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: 23560030
• Report Number: 2955842-2025-44593
• Device Sequence Number: 18675132
• Product Code: NAY
• UDI-Device Identifier: 10886874117115
• UDI-Public: (01)10886874117115(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 11/14/2025

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-03
• Device Catalogue Number: 48345T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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