MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60 RELOAD BLUE

Model Number	48360B-10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted transhiatal esophagectomy (non-transthoracic) procedure, the staples failed to fully release from a blue sureform 60 reload, resulting in an incomplete staple line.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.An advance stapler log review shows that the sureform 60 stapler instrument was installed on the system 13 times and fired 7 reloads (2 green, 1 blue, 4 green).On installs 1, 4, and 11-13, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 2, the first 2 clamp attempts were aborted by the user.The 3rd clamp was successful, and the firing was completed with no pauses for compression.On install 3, the first clamp was successful, and the firing was completed with 2 pauses for compression.On installs 5-10, the stapler failed to initialize with the system.Parameters of the errors indicate that high drivetrain friction was detected.There were no stapler related errors in the logs.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Additional Manufacturer Narrative
Updated sections: d9, h2, h3, h6, h11.Device evaluation: intuitive surgical, inc.(isi) received the blue sureform 60 reload for failure analysis (fa).The blue reload was returned fully fired, and all staples were deployed from their respective pockets.The knife was located at the distal end of the blue reload, and multiple staples were found lodged around the knife stopping point.Additionally, cartridge damage was observed, including multiple surface indentations and skiving along the knife track.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60 RELOAD BLUE
• 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: 22629370
• Report Number: 2955842-2025-31808
• Device Sequence Number: 18141132
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K10241121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 48360B-10
• Device Catalogue Number: 48360B
• Device Lot Number: K10241121 1121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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