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

Model Number	48360B-08
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 60 stapler instrument was analyzed and found to have a lodged staple in the i-beam assembly.The instrument was placed on an in-house system and found to fail initialization on 3 of 3 attempts.There was no visible damage to the instrument.The i-beam assembly was extended, and a staple was found to be lodged inside.The staple was removed, and the instrument was reinstalled on the in-house system.It passed the initialization, recognition and engagement tests on 3 of 3 attempts.The root cause is attributed to the component's susceptibility to damage.The instrument was found to fail during initialization based on in-house testing and log review.Additionally, the instrument was found to have a high drivetrain friction initialization failure based on log review and during in-house testing, preventing the stapler from entering into following.The sureform 60 blue reload has been returned and evaluated by the failure analysis team.The reload was found to have lodged staples wedged in between the reload in front of the knife.Visual inspected confirmed that there were 2 lodged staples ahead of the blade.There was also cartridge damage observed.There was no firing failure confirmed in the instrument's procedure logs.The reload was found to have damage at the site of the lodged staples.The reload cover was removed, the knife was inspected, and the damage was found on the blade.The reload blade had mechanical indentations.The probable root cause is attributed to loose staples from firing across staple lines or not having a full bundle of tissue between the jaws during use.Loose staples that do not go into tissue can be dragged into the i-beam slot as the i-beam retracts during unclamping.Increased drive train friction during calibration due to a staple lodged in the path of the i-beam can prevent the instrument from registering the reload color, which then results in an initialization failure.
Event or Problem Description
It was reported that during a da vinci-assisted procedure, the sureform 60 stapler instrument had fired twice but would not initialize the third fire.The customer changed the third fire out to make sure it was not the staple load.Procedure was completed with no patient harm.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLUE
• 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: 24507973
• Report Number: 2955842-2026-14936
• Device Sequence Number: 18774996
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 48360B-08
• Device Catalogue Number: 48360B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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