MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD GREEN

Model Number	48345G-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform stapler 45 instrument had poor movement.The procedure was completed with no reports of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the sureform stapler 45 instrument was not recognized when it was installed on the system.The issue did not occur with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue did not occur while the surgeon was attempting to manipulate instruments from the surgeon console.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci products to perform failure analysis.The sureform stapler 45 instrument has been returned and evaluated by the failure analysis (fa) team.Fa investigations did not replicate nor confirm the customer reported complaint.Visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.The stapler instrument was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using two reloads, one green and one white.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.The review of the instrument logs was unable to verify any failures.The green reload that was returned with the instrument was noted to have a lodged staple.This is likely why the customer assumed that there was an instrument failure.The instrument was fully functional.There was no problem detected.The sureform stapler 45 green reload accessory was returned and evaluated by the failure analysis (fa) team.Fa investigations replicated/confirmed the customer reported complaint.The reload was found to have lodged staples wedged in between the reload.Visual inspection confirms there are 2 lodged staples at the distal end of the reload.The reload knife was not exposed.The staples were removed from the knife track, and there was cartridge damage and blade damage to the knife.Additionally, the reload was found to have cartridge damage located at the site of the lodged staples.The knife was inspected, and damage was found.The reload blade was found to have mechanical indentations.The reload cover was removed, and the knife was inspected.The damage was found on the blade.The probable root cause of the sureform 45 reload is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instruments or hard surfaces.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD GREEN
• 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: 23065860
• Report Number: 2955842-2025-37802
• Device Sequence Number: 15915045
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)N/A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• 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): 08/21/2025

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: 48345G-01
• Device Catalogue Number: 48345G
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2020
• 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