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

Model Number	480445-06
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 45 stapler instrument misfired.The user completed the procedure and no known impact or patient consequence was reported.Intuitive followed up and obtained additional information: the event did not involve a failure to fire or a partial fire.The event did not involve tissue being pushed forward/dragged during the firing process.The event did not involve the stapler jaws opening/releasing during the firing sequence.There were no malformed or unformed staples in the staple line.The reload was not stuck to tissue.There were no staples missing from the staple line.There were no holes/gaps observed within the staple line.The green reload was inserted, automatically selected the blue reload, and would not change.Once the stapler was removed, the jaws were locked.A green and blue reload was involved with the reported event.The surgeon was able to resolve the issue with a new stapler.There was no bleeding observed on the staple line due to the stapler issue.The surgeon did not encounter any obstructions such as clips, staples, or other hard material between the instrument jaws or fire over an existing staple line.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the stapler sureform 45 instrument to perform failure analysis.The reported issue with the instrument could not be replicated or confirmed.A visual inspection displayed no signs of physical damage.The channel sprang back open when in the unclamped state.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.The stapler was tested in-house, and the instrument initialized, clamped, fired, and unclamped without any issues.The instrument fired successfully twice using two green 45 reloads.The cutline appeared smooth and consistent, with no jagged edges or tear in observed.All staples were deployed and correctly formed into the prop b-shape.The instrument was confirmed to be used on a dv5 system.The instrument was fully functional.There was no problem detected.

• 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: 24538984
• Report Number: 2955842-2026-15038
• Device Sequence Number: 18394437
• Product Code: NAY
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)K14251030
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/06/2026

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: K14251030 0059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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