MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SINGLE-SITE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	428054
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Robot xi suction irrigator was stuck inside trocar.So, the trocar was removed safely from patient, and a new trocar was placed.

• Brand Name: SINGLE-SITE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 23411930
• Report Number: 23411930
• Device Sequence Number: 9028391
• Product Code: GCJ
• UDI-Device Identifier: 00886874117293
• UDI-Public: (01)00886874117293
• 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): 09/26/2025
• Report Date (Section F): 09/26/2025

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: 428054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 09/26/2025