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

Model Number	48345G-03
Medical Device Problem Codes	Failure to Form Staple (2579); Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.A stapler log review showed the sureform 45 stapler instrument (part #480445-04, lot #t10240410-0541) was installed on the system 3 times and fired 2 green sureform 45 reloads.On install 1, a green sureform 45 reload was loaded; however no clamping or firing was attempted.On install 2, the first clamp was successful, but was followed by a firing failure.The firing stopped at approximately 80% completion.On install 3, the first clamp was successful, and the firing was completed with no pauses for compression.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted proximal gastrectomy procedure, a partial stapler fire occurred while firing a green sureform 45 reload with a sureform 45 stapler instrument.Tissue was pushed forward/dragged during the stapler firing process to create the anastomosis.The error occurred on the first stapler fire, displaying a "tissue too thick to continue" message.Additionally, the stapler reload had an exposed blade, malformed/unformed staples were observed, and the stpale line had missing staples.There was no reported bleeding.The stapler instrument was removed and upon reloading the stapler, a dent was observed.No obstructions such as clips, staples, or other hard materials were found between the instrument jaws.The instrument had been inspected prior to use and there was no damage or anything out of the ordinary that was noted.The issue was resolved by using a second green sureform 45 reload with the same stapler instrument.No additional tissue removal was necessary, and the procedure was completed robotically.
Additional Manufacturer Narrative
Updated sections: d9, h3.Device evaluation: intuitive surgical, inc.Received the green sureform 45 reload to perform failure analysis and was able to confirm and replicate the customer reported complaint.The stapler reload was found to have the knife exposed within the knife track, towards the proximal end.No damage was found to the blade.The stapler reload was also found to have cartridge damage.A piece of the cartridge was found dented on one side with the staplers undeployed.The stapler reload had cartridge surface damage in the form of a large dent towards the distal end.The dent was located distal to the knife stopping point.The complaint states that the stapler reload was inspected before use, and no dent was observed, indicating that the dent likely occurred during use or removal of the reload.The dent was noticed during installation of the second stapler reload.The second green stapler reload was fired without issue, with the same instrument.
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: 21531348
• Report Number: 2955842-2025-02256
• Device Sequence Number: 13151705
• Product Code: GDW
• UDI-Device Identifier: 10886874117092
• UDI-Public: (01)10886874117092(10)U81241003
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: U81241003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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