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

Model Number	48360B-10
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The sureform 60 blue reload accessory was an incidental return with no allegation made against this product.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a sureform (sf) 60 blue reload to perform failure analysis.The sf blue reload was found to have loose staples stuck in front of the knife.The reload was analyzed and found to have loose staples stuck in front of the knife.A visual inspection found the sf blue reload was partially fired approximately 90 percent through the firing process.There were 2 lodged staples, which could prevent the progression through the full firing trajectory.The probable root cause is attributed to loose staples from firing across staple lines or not having a full bundle of tissue between the jaws during use.

• 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 ; +1(408)523-2100
• MDR Report Key: 50486951
• Report Number: 2955842-2026-37090
• Device Sequence Number: 18676114
• Product Code: GDW
• UDI-Device Identifier: 10886874113834
• UDI-Public: (01)10886874113834(10)K10251209
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/27/2026

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: 48360B-10
• Device Catalogue Number: 48360B
• Device Lot Number: K10251209
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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