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

Model Number	48345G-03
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted distal gastrectomy surgical procedure, the sureform 45 stapler reload had exposed blade.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the sureform 45 stapler instrument and two green reloads to perform failure analysis.The stapler instrument was analyzed and found to have no signs of physical damage.The stapler was tested on an in-house system where, it initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using two blue 45 reloads.The channel sprang back open when in an unclamped state.The cutline appeared smooth and consistent, with no jagged edges or tearing to be observed.All staples were deployed and correctly formed into the proper b-shape.A review of logs and in-house of testing of instrument could not verify any firing failures.The first green reload was returned unused and unfired along with the stapler instrument.Visual inspection displayed no signs of physical damage to the cartridge, knife, pushers, or cover.It could be attached and removed from the instrument without any issues on multiple attempts.The stapler instrument initialized, clamped, fired, and unclamped without any issues using the returned reload.The reload cover was removed and was inspected after firing.There was no damage to the reload or its components.The second green reload was analyzed and found to have a lodged staple.The staple was wedged into the reload near the blade stopping point, although, it progressed through the full firing trajectory.There was no exposed blade, but the lodged staple was exposed and was sticking above the surface.The cartridge was damaged at the site of the lodged staple.The reload cover was removed along with the knife.The knife was found to have damage and mechanical indentations on it.The probable root cause is attributed to a loose staple that has become lodged in front of the knife at the distal end.All pushers appeared to have been deployed and the shuttle is fully distal, indicating a successful fire to the system.Based on the damage to the knife tack near the lodged component, it seems likely that the loose staple was caught on the knife during the fire.As the knife retracted into the cartridge at the end of the fire, the staple was pulled into the knife track.

• 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: 23311955
• Report Number: 2955842-2025-40773
• Device Sequence Number: 4967616
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(17)280131(10)K10250116
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2025

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-03
• Device Catalogue Number: 48345G
• Device Lot Number: K10250116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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