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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The instrument reported issue could not be replicated during in-house testing.The instrument was installed on the in-house system and passed initialization (engagement and recognition), intuitive motion test and reload recognition during the process.The instrument was found to have a firing failure based on log review but was not replicated through in-house testing.The logs showed the firing status as ¿tissue too thick to continue¿ message during log review.The instrument was successfully fired with no issue during in-house testing.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the sureform 30 stapler was difficult to open.The user was completing the procedure as planned using a backup sureform 30 stapler with no further issue reported.No known impact or patient consequence was reported.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the customer and obtained additional information.The sureform 30 stapler instrument jaws were not stuck on the tissue.The instrument jaws were successfully opened intraoperatively.There was no adverse effect to the tissue grasped.There was no unexpected tissue removal.Isi did receive the da vinci product with an alleged issue to perform failure analysis.Advanced investigation is performed.Initial findings were confirmed.The procedure logs were reviewed and confirmed that there was a tissue too thick to continue firing failure on the only install of this instrument in the procedure.There were no clamping or unclamping failures per the logs.The instrument was manually articulated through all axes and no issues were detected.The instrument jaws open and close as expected.The housing was removed and cables were confirmed to have adequate tension.The instrument driver was extended without issue.The jaws were free of obstructions and debris.The partial fire was not replicated through in-house testing, but was confirmed to have occurred in the field.

• 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: 23066935
• Report Number: 2955842-2025-37968
• Device Sequence Number: 9850344
• Product Code: GDW
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)K10250213
• 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
• Report Date (Section B): 08/25/2025

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: 488530-13
• Device Catalogue Number: 488530
• Device Lot Number: K10250213 0060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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