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

Model Number	480545-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.A review of the information associated with this event has been performed by post market failure analysis engineer (fae).The following additional information was provided: logs show pn 480545-06, ln k14251120-0324, was installed on the system 2x and fired 2 white reloads.On install 1, the first clamp was successful, and the firing was completed with no pauses for compression.On install 2, the system failed to detect the reload color and the user manually selected the white reload via the surgeon side console (ssc) touchpad.The first clamp was successful but was followed by a firing failure.The firing stopped at ~71% completion, after a duration of ~25 seconds.The instrument was then removed and not used in the procedure again.There were no stapler related errors in the logs.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, while firing across a vessel, the curved-tip sureform 45 stapler instrument was stuck on tissue after a partial fire.The curved-tip sureform 45 stapler generated a message that the tissue was too thick but was not given the option to force fire.The surgeon stated that the issue was under control and no immediate assistance was needed.The circulator stated that they would call if any further assistance was needed.The technical support engineer (tse) recommended to the circulator that they return the instrument and reload involved in the incident.The user completed the procedure and no known impact or patient consequence was reported.
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.Failure analysis investigations did not replicate but confirm the customer complaint "while firing across vessel, surgeon received message that tissue was too thick but was not given the option to force fire".The stapler instrument was found to have one firing failure based on log review which was not replicated through in-house testing.The stapler was installed onto an in-house system and fired on a test foam using an in-house green sureform 45 reloads.The instrument fired successfully twice, and the resultant staple-line was visually inspected.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.The white sureform 45 reload was received for analysis.Failure analysis investigations did replicate and confirm the customer complaint.The reload was found to have the blade rotated within the knife track.The blade was not exposed above the surface.There was also cartridge damage noted at the site of the rotated blade.The blade was rotated towards the distal end of the returned reload, which aligns with the firing completion percentage 71.707016 displayed in the logs.The reload was found to have cartridge damage.The cartridge was damaged between the knife track at the site of the blade rotation.The reload parts were separated for further investigation.The blade was also damaged.The reload cartridge was damaged and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the reload.The reload blade was found to have mechanical indentations.The reload parts were separated for further investigation.The blade was damaged the tip, as a result of the rotated blade.The probable root cause of reload damage is attributed to damage during user handling.Damage to the proximal end is likely caused by mishandling while either installing or removing the reload.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 CURVED-TIP
• 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: 24834582
• Report Number: 2955842-2026-20717
• Device Sequence Number: 10201605
• Product Code: NAY
• UDI-Device Identifier: 10886874117597
• UDI-Public: (01)10886874117597(10)K14251120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190999
• 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
• Report Date (Section B): 05/07/2026

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: 480545-06
• Device Catalogue Number: 480545
• Device Lot Number: K14251120 0324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian