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

Model Number	48230W-06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sureform 30 white reload accessory has been returned and evaluated by the failure analysis (fa) team.Fa investigations replicated/confirmed the customer-reported complaint of 'partial damage when cartridge is installed'.The accessory reload was returned with a broken switch.The accessory reloads had a broken/damage cartridge at the tail of the reload.The broken tail was returned with the reload in the original but opened package.The root cause of this failure is attributed as component's susceptibility to damage.Additionally, the accessory reloads had a partially deployed pusher.Visual inspection showed one pusher was deployed halfway from its normal position/location.The accessory reload was found to have missing staples.Visual inspection showed that 2 staples were missing from the cartridge.The staples most likely fell out during the installation of the reload without using the installation tool.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the sureform 30 white reload accessory exhibited partial damage when it was installed.No fragment fell into the patient.The procedure was completing as planned with no reported injury.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Initial findings were confirmed.The white reload accessory was analyzed and it was returned with a broken tail.The tail of the cartridge was completely separated from the body of the cartridge.The switch component was intact and still sitting within the tail.The switch component was not broken.Additionally, there are two missing staples from the proximal end on the left side, however all pushers were present.There were no fully deployed pushers, as the reload was not fired.The reload cannot be fired from the stapler with a broken tail, as the switch would be installed into the incorrect location of the stapler channel, preventing stapler installation.The complaint was confirmed by failure analysis.

• 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: 23889753
• Report Number: 2955842-2025-49641
• Device Sequence Number: 18507778
• Product Code: NAY
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)U10250224
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211997
• 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): 01/14/2026

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
• Device Lot Number: U10250224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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