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

Model Number	48230W-06
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis, and the complaint was confirmed.The stapler 30 white reload was analyzed and found with a broken tail.There was no material missing as a result of the break.Due to the break in the tail, the reload could not be successfully installed onto a reload.Additional findings not reported by site: the reload was found to have a broken switch.The broke piece measures approximately 1.00mm x 2.13mm.The broken piece was not returned.The reload was found to have a detached fragment.The fragment broke off from the reloads switch.The broken switch piece was not returned with the reload.The reload was found to have staples missing at the proximal end of the reload.A total of four staples were missing from the reload pockets.The reload had not been fired.Missing staples at the proximal end typically occur when there is an attempt to install a reload onto an instruments jaw without using the installation tool.The stapler 30 white reload accessory was further evaluated by failure analysis engineer (fae).Initial findings were partially confirmed.A white reload was returned with a stapler instrument, which logged a firing failure with a gray reload.Due to this discrepancy, the investigation cannot confirm that the returned reload was involved in the reported event.The returned reload exhibits significant damage, including a broken tail, broken switch, and missing staples.The condition of the reload indicates that a partial fire event likely occurred.The staples were likely deployed during the firing event, which was expected.The observed damage is consistent with misalignment during reload installation.The broken tail and displaced switch suggest the reload may have been inserted at an angle, allowing interference with channel features and resulting in deformation of the tail and dislodgement of the switch.The switch component may have subsequently fragmented during firing, contributing to the observed missing components.While the exact relationship between this reload and the logged firing failure cannot be confirmed, the damage mechanism observed represents plausible contributor to a firing failure.Improper alignment during installation remains the most probable cause of the observed reload damage.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the stapler 30 white reload would not load then failed to fire.The procedure was completed with no patient harm.

• 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: 25630207
• Report Number: 2955842-2026-30034
• Device Sequence Number: 18590243
• Product Code: GDW
• UDI-Device Identifier: 10886874121921
• UDI-Public: (01)10886874121921(10)K10250619
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: K10250619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White