MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	488530-13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 30 curved-tip stapler instrument would not open and had to be manually opened.No fragment fell into the patient.The customer completed the procedure with the same instrument and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the sureform 30 curved-tip stapler instrument associated with this complaint and completed investigations.The instrument was found to have a lodge component in one of the jaws.It was manually articulated the grip axis and was not actuating as expected.Visual inspection showed a lodged component/material inside the jaws.Attempted to remove the lodged component and was not able to dislodge the material during the process.Also, it was installed a ¿white reloads¿ and had a sitting issue (won't lock-in).The failure analysis was unable to perform clamping and firing an in-house reloads due to the lodged component.The lodged unknown material most likely the cause of the issue from the field.Logs show stapler was installed on the system 7x and fired 1 gray reload.On installs 1, 2, and 4-7, the system failed to detect a valid reload was installed during installation.On install 3, a gray reload was installed.The first clamp was successful but was followed by a firing failure.The firing stopped at about ~37% completion, after a duration of ~22 seconds.After the 7th install attempt, the instrument was removed and not used again in the procedure.There were no stapler related errors in the logs.
Additional Manufacturer Narrative
The engineering review was performed and additional information was received: initial findings were confirmed.The procedure logs were reviewed and confirm 6 installs where no valid reload could be detected by the system.On the 3rd install of the procedure, a gray reload was detected.The clamp was successful; however, the firing failed at ~37% completion.The subsequent unclamp was successful and there were no indications in the logs that the manual release was used while the instrument was on the system.A reload could not be fully seated within the jaws and the jaws were unable to fully close, indicating a potential lodged component.The instrument jaws were disassembled and revealed two lodged switch fragments within the knife track of the channel.Additional damage was observed to the cutting edge of the driver.Based on the switch fragments observed within the jaws and the damage the driver knife, it is likely that the switch component of the reload was misaligned within the channel during reload installation.During reload detection, the driver likely hit the misaligned switch component resulting in an invalid reload color result.On one install, it is likely the switch was lodged in a location that allowed for proper reload detection.Once firing was initiated, the instrument was fired across the lodged switch component.The force of the interaction resulted in a force increase past the pre-determined force threshold, resulting in the partial fire.The lodged fragment likely also contributed to the subsequent reload recognition failures as the system could not detect the correct position of the switch on the installed reload and instead detected the fragment at an incorrect position.A lodged switch component is a result of improper reload installation, which is attributed to the user.Proper use of the installation tool will ensure the reload tail and switch are aligned within the channel during seating, preventing damage to the instrument and reload.The probable root cause of the lodged fragments within the jaws is attributed to an improper reload installation by user.Proper use of the installation tool will ensure the reload tail and switch are aligned within the channel during seating, preventing damage to the instrument and reload.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 24251668
• Report Number: 2955842-2026-03095
• Device Sequence Number: 18556268
• Product Code: NAY
• UDI-Device Identifier: 10886874121723
• UDI-Public: (01)10886874121723(10)U11250904
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• 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): 03/10/2026

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: 488530-13
• Device Catalogue Number: 488530
• Device Lot Number: U11250904 0096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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