MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	CTF03
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was inserting a trocar -obturator bent.

• Brand Name: KII FIOS FIRST ENTRY
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 23402064
• Report Number: 23402064
• Device Sequence Number: 10047440
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/03/2025
• Report Date (Section F): 10/03/2025

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: CTF03
• Device Lot Number: 1558059
• 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: 10/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• 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: 23 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 10/03/2025