MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number	480460-12
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 60 stapler instrument was inserted and was unable to close on the tissue.The sureform 60 stapler instrument was removed and reinserted, but the instrument went the opposite way of the track lines.The customer completed the procedure and 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) has received the sureform 60 stapler instrument to perform failure analysis.The reported issue could not be confirmed nor replicated.A visual inspection revealed no signs of physical damage.The channel sprang back as expected when the instrument was unclamped.Recognition and engagement tests passed successfully.The sureform 60 stapler instrument operated intuitively, achieving its full range of motion in all directions.The grips opened and closed properly.In-house testing confirmed that the stapler initialized, clamped, fired, and unclamped without any issues.The sureform 60 stapler instrument fired successfully using green 60 reloads.The cutline was smooth and consistent, with no jagged edges or tearing observed.All staples were deployed correctly and formed the proper b-shape.A review of logs did not indicate any failures.The instrument was found to be fully functional and unused, with no problems detected.Isi has received the sureform 60 white reload to perform failure analysis.The reported issue could not be confirmed nor replicated.Upon investigating the reload, no damage was found.This complaint does not affect the functionality of the reload.No device-related failures were identified.The reload was returned unused and unfired and was processed with the instrument.A visual inspection showed no physical damage to the cartridge, knife, pushers, or cover.The reload was attached to an in-house golden instrument and operated on an in-house system.Attachment and removal from the instrument were performed multiple times without any issues.The instrument passed recognition and engagement tests, and successfully initialized, clamped, fired, and unclamped using the returned reload.After firing, the reload cover was removed and inspected.No damage to the reload or its components was found.No product issue was identified.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60
• 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: 24690967
• Report Number: 2955842-2026-17239
• Device Sequence Number: 10067356
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K11250912
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K11250912 0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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