MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30 RELOAD GREEN

Model Number	48630G-05
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.An advance stapler log review show the sureform 30 stapler instrument, was installed on the system 5 times and fired 5 reloads (3 white, followed by 2 green).On installs 1, 2, and 5, the first clamps were successful, and the firings were completed without error.On install 3, the first clamp was incomplete.The next clamp was successful, and the firing was completed without error.On install 4, the first clamp was incomplete.The next clamp was successful but was followed by a firing failure.The logs showed an error code, representing the failure.All unclamps were successful.There were no additional stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy procedure, a partial fire occurred when the green sureform 30 reload stopped midway through deployment, requiring a more extensive closure of the pulmonary bronchus.Although clamping initially functioned as expected an error message ¿unable to complete fire, blade may be exposed¿ was displayed during the partial fire.The surgeon did not encounter any obstructions, such as clips, staples, or other hard materials between the instrument jaws; however, the bronchial tissue was described as thick.To address the defect, a series of sutures were placed along its length to retract the tissue, allowing a second staple reload to be successfully fired across the open area.While there was no bleeding, the stapling event resulted in unplanned tissue removal.Hemostatic glue was also applied to reinforce the closure.The procedure was successfully completed robotically.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30 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: 22187323
• Report Number: 2955842-2025-24330
• Device Sequence Number: 18296926
• Product Code: GDW
• UDI-Device Identifier: 10886874112844
• UDI-Public: (01)10886874112844(10)K10240530
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 48630G-05
• Device Catalogue Number: 48630G
• Device Lot Number: K10240530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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