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

Model Number	488530-13
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was addressed with phone support.The fse replaced the stapler during the procedure.No site visit was conducted.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure; the surgeon was unable to unclamp with using the curve-tip sureform 30 stapler on universal surgical manipulator (usm) 3.Use of the instrument was discontinued, and it was replaced to the backup.The technical support engineer (tse) confirmed the engagement issue on usm 3 in the logs.The tse explained to the customer that the issue was possibly caused by poor sterile adapter (sa) attachment and advised the customer to reseat the sa if the issue reoccurred.The user completed the procedure and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical inc (isi) followed up with the initial reporter and obtained additional information: the surgeon was performing a stomach resection.There was no system error.The sureform 30 stapler instrument was no longer recognized when attached to the arm.The release key was not used.The procedure was completed with no issue.There was no bleeding and no blood transfusions.There were no fragment fell.The instrument will be returned for evaluation.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: 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: 23018840
• Report Number: 2955842-2025-37465
• Device Sequence Number: 9665392
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)U12241219
• 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): 10/27/2025

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: U12241219 0061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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