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

Model Number	48360B-09
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci assisted general surgery procedure, the staples from a blue sureform 60 reload did not close all the way and staples fell into the surgical site.The procedure was being completed as planned.
Additional Manufacturer Narrative
No product has been returned to intuitive surgical, inc.(isi) for evaluation.Due to insufficient procedural information, further system/instrument log investigation could not be performed.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Updated fields: h2, h10, h11.The sureform 60 reload associated with this report was not returned for failure analysis.Additional information: a concomitant product, the sureform 60 stapler used to fire the blue reloads, and another blue reload were received and failure analysis investigations were performed.These products were received in reference to mdr with mfr report number 2955842-2025-24052.The sureform 60 stapler instrument for failure analysis investigation.System logs showed firing failure and incomplete (hi torque) errors.The sureform 60 stapler instrument was placed and driven on an in-house system.The instrument was fully functional.No product issue was identified.The blue sureform 60 reload was returned in used condition.A visual inspection discovered that the stapler reload was partially fired.Further inspection revealed that, up to this firing interruption, all staples were fired, the shuttle was okay, and the shuttle knife had damage.The reload was found with a damaged blade inside the cartridge track.Further inspection revealed that the blade had mechanical indentations.A visual inspection did not show blade rotation.The reload was found to have a cartridge damage along the top surface.The surface showed bulges at the point where the knife stopped.Additionally, the stapler logs for this procedure were reviewed.The stapler instrument was installed on the system 5 times and fired 5 reloads (1 green, 4 blue) during the procedure.On installs 1, 3, and 4, the first clamp was successful, and the firings were each completed with no pauses for compression.On install 2, all clamps were successful, and the firing was completed with 1 pause for compression.A firing failure was observed on the fifth fire with a representative error.Another stapler instrument was installed to continue the procedure.

• 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: 22149225
• Report Number: 2955842-2025-24054
• Device Sequence Number: 18262164
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(17)260131(10)K10240111
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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-09
• Device Catalogue Number: 48360B
• Device Lot Number: K10240111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2024
• 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