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

Model Number	488530
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When trying to fire the stapler with the dv5 system, repeated errors stating that no stapes loaded or staples previously used were given by the system.The stapler and all error loads were saved.

• Brand Name: SUREFORM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 23782981
• Report Number: 23782981
• Device Sequence Number: 5029792
• Product Code: GDW
• UDI-Device Identifier: 00886874121726
• UDI-Public: (01)00886874121726(10)K10250717(17)270731(11)250717
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2025
• Report Date (Section F): 10/24/2025

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
• Device Model Number: 488530
• Device Lot Number: K10250717
• 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: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/24/2025