MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45

Model Number	480445-06
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the sureform 45 stapler instrument for evaluation, but evaluation has not been completed as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary segmentectomy surgical procedure, the sureform 45 stapler instrument was stuck in the cannula.Once removed, the joint was found to be cracked.The user completed the procedure and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer reported that the instrument was inspected prior to the procedure.The instrument did not collide with other instruments, and no fragments fell inside the patient.There was no report of patient injury.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform stapler 45 instrument was analyzed and found to have the snake wrist cover torn.The tears measured roughly 0.107"- 0.408".A visual inspection displayed no signs of missing fragments.The reload was returned with the stapler and was analyzed.The reload showed no signs of damage, and was unused and unfired, and did not proceed with the instrument.A visual inspection confirmed no abnormalities in the cartridge, knife, pushers, or cover.The reload was installed onto an in-house golden instrument, which was driven on a system; the reload attached to and detached from the instrument without difficulty on multiple attempts.Both the instrument and reload passed recognition and engagement tests.Overall, no device-related failures were found, and the reload was confirmed to be fully functional.The complaint was confirmed by failure analysis.The probable root cause of damaged snake wrist cover is attributed to user-related factors, including device handling during use or sample handling.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45
• 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: 22985894
• Report Number: 2955842-2025-37177
• Device Sequence Number: 18377063
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K11250307
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: 0140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 10/31/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/07/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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