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

Model Number	488530-13
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the blade broke off the curved-tip sureform 30 stapler instrument after the reload was removed.No fragment fell into the patient.The customer completed the procedure and no known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the broken part of the blade was sent back.Also, there was no photos or videos available patient information cannot be provided.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the curved-tip sureform 30 stapler instrument associated with this complaint and completed investigations.The instrument was installed on the in-house system with an in-house white reload with no issue.The instrument fired successfully, and the resultant staple-line was visually inspected.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.
Additional Manufacturer Narrative
The curved-tip sureform 30 stapler instrument was transferred to engineering to confirm the loose component as a switch from an unknown reload.The instrument logs were reviewed and confirm successful reload detection and firings on 4 of 4 installs in the field.There were no errors detected in the logs.The instrument was returned with a whole switch component outside of the device.The returned component is not a component of the stapler and is a component of a reload.The instrument was installed on an in-house system and was recognized appropriately.The reload color was detected and the instrument clamped, fired, unclamped, and moved intuitively.There were no functional issues detected via log review nor in-house testing.The switch component was likely pulled from a reload during the reload installation process in the field.As the switch was not found lodged in the instrument and the reload from which it was pulled was not returned, the investigation is unable to confirm any failures related to the device itself.The complaint was confirmed by failure analysis.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24318068
• Report Number: 2955842-2026-04095
• Device Sequence Number: 17359278
• Product Code: GDW
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)K12251120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 03/11/2026

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: K12251120 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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