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	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lobectomy.Event description: trocar used in a thoracic surgery (lobectomy) for the scope access (only trocar used.Also using alexis for instruments access).Trocar was placed with rotation, as usual, in a intercostal space.The event occurred in the middle of the surgery after inserting the scope (removed to clean the scope) and start manipulating it.The trocar was used for scope access and during the surgery, after the scope insertion and some manipulation, the team heard a cracking sound and realized the trocar broke in the middle of the canula.No fragments identified.No impact in the patient status.Additional information received from an applied medical representative via email on 20mar2025: there was difficulty during insertion and was not used with a robot.Intervention: the surgeon removed the trocar and placed a new one.Patient status: patient is ok.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula shaft.Based on the provided photograph and the description of the event, it is likely that the reported event was caused by manipulation within the cannula.However, in the absence of the event unit, applied medical is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: lobectomy event description: trocar used in a thoracic surgery (lobectomy) for the scope access (only trocar used.Also using alexis for instruments access).Trocar was placed with rotation, as usual, in a intercostal space.The event occurred in the middle of the surgery after inserting the scope (removed to clean the scope) and start manipulating it.The trocar was used for scope access and during the surgery, after the scope insertion and some manipulation, the team heard a cracking sound and realized the trocar broke in the middle of the canula.No fragments identified.No impact in the patient status.Additional information received from an applied medical representative via email on 20mar25: there was difficulty during insertion and was not used with a robot.Intervention: the surgeon removed the trocar and placed a new one.Patient status: patient is ok.

• 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: 21713299
• Report Number: 2027111-2025-00446
• Device Sequence Number: 13249894
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: CTF73
• Device Catalogue Number: 101476489
• Device Lot Number: 1537531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED BIPOLAR ENERGY, GRASPER, ALEXIS.
• Patient Sex: Unknown