MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM; STAPLE, IMPLANTABLE

Model Number	480545
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a robotic thoracic procedure, a disposable robotic stapler was being placed.The stapler would not advance fully through the trocar and there was additional difficulty when attempting to remove the device.The stapler was not on tissue and was not used prior to being removed completely from the patient.Once removed, the team at the surgical field inspected the device and noticed a piece seemed to be missing from the "sheath" at the wrist of the stapler.

• Brand Name: SUREFORM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 24291366
• Report Number: 24291366
• Device Sequence Number: 18474690
• Product Code: GDW
• UDI-Device Identifier: 00886874117590
• UDI-Public: (01)00886874117590
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2026
• Report Date (Section F): 01/19/2026

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
• Device Model Number: 480545
• Device Lot Number: K11250828
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/19/2026