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

Model Number	470500
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The case was a robotic laparoscopic hysterectomy bilateral salpingectomy.When the obturator was put through trocar, dr.[redacted] saw that a small portion of the seal had broken off into the patient.

• 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: 25425813
• Report Number: 25425813
• Device Sequence Number: 10322499
• Product Code: GCJ
• UDI-Device Identifier: 00886874116401
• UDI-Public: (01)00886874116401(11)260211(17)280229(10)K12260211
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/13/2026
• Report Date (Section F): 05/13/2026

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: K12260211
• 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: 06/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Date Report Sent to FDA: 05/13/2026