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

Model Number	48345G-03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the product for failure analysis evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, when attempting to separate the bronchus of s6, a tissue too thick to continue (tttc) message occurred and the fire stopped.Upon opening the jaws, a b-shaped formed staple and a fragment of debris fell on the bronchus.The tissue was not dissected, and there was no bleeding.The doctor mentioned that the debris might have prevented the fire from completing.This reload was the second fire within the procedure.The first fire was completed without issues.After the incident, a new sureform 45 stapler and green reload were used, and the fire was completed without problems.The debris will be returned together with the reload.
Additional Manufacturer Narrative
Updated fields: d9, h2, h3, h6, and h11.Device evaluation: the green sureform 45 reload was received for failure analysis evaluation.The stapler reload was found to have the blade rotated within the knife track.The blade was not exposed above the surface.There was also cartridge damage noted at the site of the rotated blade.Additionally, the stapler reload was found to have cartridge damage.The cartridge was damaged between the knife track at the site of the blade rotation.The sureform 45 stapler instrument was also received and failure analysis found the instrument to have 1 firing failure based on log review which was not replicated through in-house testing.The stapler instrument was installed onto an in-house system and fired on a test foam using two in-house green sureform 45 reloads.The instrument fired successfully, and the resultant staple-line was visually inspected.The cut-line appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated sections: h2, h6, h11.Further investigation and evaluation of the green sureform 45 reload confirmed the initial failure analysis findings.The rotated blade was found lodged into the left side t-slot wall, and removal of the blade and shuttle revealed additional skiving cartridge damage to the bottom edge of the wall.Significant cartridge damage was observed near the blade¿s final location, resulting from blade rotation and subsequent deformation of the fractured shuttle knife seat, and allowed the blade to contact the t-slot wall.Minor damage was observed on the cutting edge of the blade near its center.The skiving to the reload t-slot, shuttle damage, and blade rotation indicate that force caused the blade to become dislodged from its proper position within the knife seat as it was pushed forward by the i-beam during firing.No material appears to be missing from either the cartridge or the shuttle.A review of a video provided by the customer shows a sureform 45 curved-tip stapler instrument with a green sureform 45 reload installed on arm #3.At one point during the video, the surgeon clamps and initiates firing on the bronchus, with some formed staples already visible in the frame.When the stapler instrument reaches 24mm, it pauses for compression before partially firing and displaying the messages: "tissue too thick to continue" and "tap blue pedal to unclamp and consider changing reload color".The stapler instrument is removed from the bronchus, revealing unformed staples at the distal end of the staple line and formed staples near the proximal end.Additionally, a fragment of the green stapler reload is visible at the proximal end of the bronchus.The bronchus does not appear to have been transected.The surgeon then proceeds to remove the green stapler reload fragment.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 22532869
• Report Number: 2955842-2025-30231
• Device Sequence Number: 20704892
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)K10241024
• 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,Followup,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48345G-03
• Device Catalogue Number: 48345G
• Device Lot Number: K10241024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 09/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown