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

Model Number	480460-12
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted left hemicolectomy surgical procedure, it was noted that when customer wanted to remove the sureform 60 stapler, there wasn't readback between surgeons.Then the jaws were folded.And they used manual released knob.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 16-feb-2026: the sureform 60 stapler was inspected prior to use.The jaws were not stuck on tissue at the time of the event.The manual release kit (mrk) worked.There was no bleeding as a result of the failure.No images were available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform (sf) 60 stapler instrument was analyzed, and the findings did not replicate or confirm the customer reported event.The instrument was placed and driven on the in-house system.The instrument passed initialization.The instrument passed the recognition and engagement tests multiple times.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.The instrument clamped, fired, and unclamped successfully.The instrument was successfully fired with a sf60 black reload.Additionally, the instrument logs were thoroughly examined, indicating no instances of engagement, initialization or recognition failures associated with the instrument.The instrument was fully functional.No product issue was found.Additional unrelated observation states that the instrument was found to have the wrist cover torn at the distal end.The component was damaged and there may be missing pieces/material, but the size of the missing pieces cannot be confirmed.Common causes of the failure mode torn wrist cover is typically attributed to the user, such as excessive contact with abrasive or hard surfaces during use or reprocessing.

• Brand Name: SUREFORM
• Common Device Name: STAPLER 60
• 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: 25131722
• Report Number: 2955842-2026-24577
• Device Sequence Number: 15783253
• Product Code: NAY
• UDI-Device Identifier: 10886874115647
• UDI-Public: (01)10886874115647(10)K17250726
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 05/08/2026

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: 480460-12
• Device Catalogue Number: 480460
• Device Lot Number: K17250726 0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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