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

Model Number	488530-13
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.The probable root cause cannot be determined based on the information provided.Since the product was not returned and the log review was inconclusive, the reported event was unable to be confirmed or replicated.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 30 stapler instrument malfunctioned and unable to recognize load once in patient, did not rotate properly.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sureform stapler instrument to perform failure analysis.The instrument was found to have failed during initialization based on log review.Review of the logs found that the instrument generated three error messages.The instrument was installed on an in-house system with an in-house reload.The instrument passed initialization tests and the jaws opened and closed properly.The instrument move intuitively with full range of motion.The reload was fired onto a test sheet with no issues.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Additional testing was performed on the returned instrument.The procedure logs were reviewed and confirmed a partial fire occurred with a white reload after the user interface was used to select the white reload color.The firing completed to 37%.On the following 3 installs, the stapler failed to initialize with the system.Parameters of the errors indicated that high drivetrain friction was detected.The initialization and firing failures were not replicated through in-house testing.The instrument was re-installed on an in-house system and initialized without error.The instrument was moved through yaw, pitch, and roll appropriately.There was no lack of roll motion once the instrument was initialized and engaged with the system.The instrument was then removed and the jaws were inspected.No damage was observed to any distal or back-end components.The driver was extended and retracted manually with no excess friction felt.The jaws sprung open when manually closed.All welds appeared intact and there were no loose or lodged components.The probable root cause of the initialization and firing failures observed in the field could not be determined.The reported failures were not reproducible during failure analysis testing, and no contributing findings were identified.

• 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: 23442650
• Report Number: 2955842-2025-43548
• Device Sequence Number: 15591560
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)K11250605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• 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,Followup,Followup
• Report Date (Section B): 01/07/2026

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: K11250605 0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 11/01/2025; 12/15/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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