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

Model Number	CFF33
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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: thoracic surgery - vats meduastinal mass excision.Event description: happened during the surgery (the team can't identify the exact moment) in the instrumentation port, using our grasper c4130 and [brand redacted] maryland alternated.They just realized there was a trocar fragment and then it was totally broken, separated in two parts.When removing the trocar, the parts were separated in the balloon area.The trocar was placed between ribs and the patient was stable with no visible thoracic contractions.No impact in the patient status.The trocar and fragments were removed and placed a new trocar to proceed with the surgery.Additional information received from an applied medical representative via email on 28apr25: the trocar was inserted with rotation alternating clockwise and counterclockwise direction with no difficulty during insertion.Robot was not used.They can´t identify the exact moment of the incident.They just realized there was a fragment.In this port it was only used an atraumatic grasper (c4130) and [brand redacted] maryland, alternated (both 5mm).Intervention: the trocar and fragments were removed and placed a new trocar to proceed with the surgery.Patient status: no impact to the patient status.

• 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: 21964724
• Report Number: 2027111-2025-00510
• Device Sequence Number: 8415207
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K083638
• 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): 06/02/2026

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1537538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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
• Patient Sex: Unknown