MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. NONE; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	470500
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While on the robot for robotic laparoscopic cholecystectomy, an instrument was placed in the trocar forcefully and cut the rubber seal off the trocar cap.It was found in the abdomen during the procedure.Confirmed at the end of the case where it came from and that we had all the pieces.

• Brand Name: NONE
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 25168185
• Report Number: 25168185
• Device Sequence Number: 13311944
• Product Code: GCJ
• UDI-Device Identifier: 00886874116401
• UDI-Public: (01)00886874116401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/11/2026
• Report Date (Section F): 05/11/2026

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: 470500
• Device Catalogue Number: 470500
• Device Lot Number: K13260122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Date Report Sent to FDA: 05/11/2026