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	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the sureform 30 curved tip stapler was unable to open.The customer tried to use the instrument multiple times but it did not work.The user completed the procedure using a backup instrument with no further issue reported.No fragment fell inside the patient.Isi followed up with the initial reporter and obtained the following additional information: the stapler functioned correctly and was removed from the patient.The staff was unable to open the instrument to put in another reload so a backup stapler was used to continue the procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A review of the logs for the sureform stapler associated with this event has been performed.Logs show pn 488530-13, ln u80240612-0136, was installed on the system 5x and fired 5 blue reloads.On each install the first clamp was successful.On installs 1-5, the firings were completed with no pauses for compression.On install 6, the firing was completed with 1 pause for compression.After the 6th firing, the instrument was successfully unclamped per the logs.Approximately 50 seconds after the successful unclamp, the grip release tool was detected on the instrument, represented by error code 22027 in the logs.The stapler was force expired as a result of the grip release detection, represented by error code 282 in the logs.A minute later, logs show two instances of error code 282, indicating that the site may have attempted to re-install the instrument two more times after the force expiration occurred.As there were no unclamp failures shown in the logs, it is unclear what prompted the use of the grip release.There were no additional stapler related errors in the logs.

• 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: 22470381
• Report Number: 2955842-2025-29122
• Device Sequence Number: 15477255
• Product Code: GDW
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)U80240612
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 06/17/2025

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: U80240612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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: Reuse
• 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