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

Model Number	48230W-06
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.The stapler has been returned and evaluated by the failure analysis (fa) team.The accessory reloads had a broken/damage cartridge at the tail of the reload.The broken switch was return with the reload attached to the tail.However, during visual inspection, the switch fell off from where it was seated.The root cause of this failure is attributed as component's susceptibility to damage.The accessory reloads had a partially deployed pusher.Visual inspection showed 4 pushers were partially deployed from its normal position/location.The root cause is not established.The accessory reload was found to have 2 staples deformed and 2 staples partially deployed (sticking out).The reload will be transferred to engineering for further analysis on the broken switch with partially deployed pusher and deformed staples.The reload came with rma (b)(4).Initial findings were confirmed for the reload.This reload came with the instrument.The procedure logs were pulled and confirm the stapler experienced a reload recognition failure on the first install in the field.The system was not able to detect a valid reload.On the next install, the gui interface was used to select the white reload color.The user then made a successful clamp and fired the instrument, which resulted in a firing failure at ~6%, which is prior to any tissue interaction.On the 3rd install, the system again failed to detect a valid reload, preventing further use of the instrument.The switch component of the returned reload was broken into multiple pieces.The instrument was found with a damaged driver cutting edge.The broken switch and damage driver indicate that the user likely fired this reload with the switch component of the reload misaligned within the instrument channel.The reload was inspected and confirmed to have a formed staple lodged the most proximal right pusher pocket.The next row of staples was beginning to deploy.The reload tail was found to be broken, as well as significant cartridge damage to the proximal knife track and the switch location within the tail.All damage is indicative of driver interaction with the switch component during the fire.It is likely that the switch component of the reload was misaligned within the channel during reload installation.With the switch misaligned, it is likely that during the fire, the driver rammed into the switch component, resulting in fracture of the switch and firing forces to spike.With the increased firing forces, the firing threshold was reached and the system halted the firing very early in the firing sequence.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.Initial findings were not confirmed for the stapler.The procedure logs were pulled and confirm the stapler experienced a reload recognition failure on the first install in the field.The system was not able to detect a valid reload.On the next install, the gui was used to select the white reload color.The user then made a successful clamp and fired the instrument, which resulted in a firing failure at ~6%, which is prior to any tissue interaction.On the 3rd install, the system again failed to detect a valid reload, preventing further use of the instrument.The instrument was returned with a white reload.The switch component of the reload was broken into multiple pieces.The broken switch indicates that the user likely fired with the switch component of the reload misaligned.Disassembly of the instrument jaws revealed no significant damage.Lockout mechanism was intact and was able to be displaced out of the channel manually.The lockout mechanism then sprang back into the channel as expected.Inspection of the lockout cover and mechanism do not show any obvious damage.There were no loose or lodged components the jaws.The driver cutting edge was inspected and found with a significant indentation to the cutting edge.Damage indicates the drive hit something hard, such as the switch component.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the stapler would not initiate.The procedure was completed with no reported injury.

• Brand Name: SUREFORM
• Common Device Name: 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: 24423891
• Report Number: 2955842-2026-06386
• Device Sequence Number: 17655375
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)NA
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 02/23/2026

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: 48230W-06
• Device Catalogue Number: 48230W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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 Sex: Unknown