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

Model Number	48230M-06
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reload involved in this complaint has not been received and/or tested by failure analysis as of the date of this report.If the product is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a da vinci-assisted wedge to completion lobectomy surgical procedure, the sureform 30 gray reload bent and broke off.The user completed the procedure with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no instrument collision during the procedure.The issue occurred while the reload was being installed.There was no fragment fall into the patient and no injury to the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The sureform 30 gray reload was analyzed, and failure analysis investigations replicated and confirmed the customer-reported complaint.The reload was found to have a fractured tail section, with the broken fragment measuring approximately 2.66 mm × 7.71 mm.While the broken tail piece was returned, the associated switch was not.Additional findings: the switch, which measures approximately 1.25 mm × 2.70 mm, was missing from the fractured tail section and was not returned with the reload.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of the broken tail and detached fragments is attributed to user-related factors, resulting in damage during use.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
The previous supplemental (mfr report number 2955842-2025-44328) had the incorrect due date of us reportability aware date of 10/14/2025 and due date of 11/13/2025.The correct us reportability aware date is 11/13/2025 and due date is 12/13/2025.

• 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: 23494232
• Report Number: 2955842-2025-44328
• Device Sequence Number: 9048235
• Product Code: GDW
• UDI-Device Identifier: 10886874121938
• UDI-Public: (01)10886874121938(10)U80240801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 48230M-06
• Device Catalogue Number: 48230M
• Device Lot Number: U80240801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 11/13/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/08/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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