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

Model Number	CTF73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lobectomy.Event description: during the procedure, the trocar was used for scope port and was places between the patient ribs.The operating room staff heard a crack noise and noticed that the trocar is broke into 2 pieces.Additional information received from an applied medical representative via email on 05mar25: there was no patient injury, they was released home.The break occurred at the shaft.The trocar was rotated alternating clockwise and counterclockwise direction with no difficulty insertion.The break was considered a clean break with no particulation.Laparoscope was inside the cannula at the time of the incident.Intervention: use a replacement.Patient status: no injury was released home.
Event or Problem Description
Procedure performed: lobectomy.Event description: during the procedure, the trocar was used for scope port and was places between the patient ribs.The or staff heard a crack noise and noticed that the trocar is broke into 2 pieces.Additional information received from an applied medical representative via email on 05mar25: there was no patient injury, they was released home.The break occurred at the shaft.The trocar was rotated alternating clockwise and counterclockwise direction with no difficulty insertion.The break was considered a clean break with no particulation.Laparoscope was inside the cannula at the time of the incident.Intervention: use a replacement.Patient status: no injury was released home.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula shaft fracture.The wall thickness of the cannula shaft near the fracture was measured and found to be uneven.Based on the condition of the returned unit and the event description, it is likely the cannula fracture was caused by a combination of uneven wall thickness and higher force during trocar manipulation due to contact with the ribs.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• Brand Name: KII FIOS FIRST ENTRY
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21560332
• Report Number: 2027111-2025-00405
• Device Sequence Number: 21136334
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: CTF73
• Device Catalogue Number: 101219101
• Device Lot Number: 1511096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPE.
• Patient Sex: Unknown