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

Model Number	480445-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, 45 sureform stapler instrument failed to open after fire.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.However, failure analysis is not complete.A review of the information associated with this event has been performed by post market failure analysis engineer.The following additional information was provided: the logs showed pn 480445-06, ln u13241115-0107, was installed on the system 2x and fired 2 blue reloads.On both installs, the first clamp was successful, and the firings were each completed with no pauses for compression.Both unclamps were shown as successfully completed, per the logs.The instrument was then removed and not used again in the procedure.There were no stapler related errors in the msc logs.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive has received the sureform 45 stapler associated with this complaint and completed investigations.Failure analysis investigations did not replicate nor confirm the customer reported complaint "it did not open after the fire".The reported event with the instrument could not be replicated nor confirmed.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 sf gray 45 reload two consecutive times.Visual inspection was performed and no damage was observed.The instrument was fully functional.No product issue was identified.Intuitive surgical, inc.(isi) followed up and obtained additional information.There was damage out of the ordinary.There was no unexpected tissue removal.There was no bleeding.Instrument available for return with sequence id (b)(4).

• 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: 23884383
• Report Number: 2955842-2025-49534
• Device Sequence Number: 4771484
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)U13241115
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183224
• 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): 02/04/2026

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: 480445-06
• Device Catalogue Number: 480445
• Device Lot Number: U13241115 0107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• 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
• Patient Sex: Unknown