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

Model Number	CFF75
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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: laparoscopic gastrectomy.Event description: during a gastrectomy performed with the [device name], a cff75 was used as the assistant port.At the time of closure, the trocar was removed and it was noticed that the distal end of the cannula was cracked.The abdominal cavity was inspected with the camera, and all fragments were retrieved, confirming that no pieces remained inside the cavity.It is unclear at what point the cannula cracked, but it was likely sometime during the latter part of the procedure.Various instruments were inserted through the port, including grasping forceps, an [company] suction device, and the [device name] stapler.No patient injury or illness associated with this event.Replaced with a hospital inventory, and the procedure was completed.Intervention: replaced with a hospital inventory and the procedure was completed.Patient status: no patient injury indicated.

• 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: 24689812
• Report Number: 2027111-2026-00458
• Device Sequence Number: 9977304
• Product Code: GCJ
• UDI-Device Identifier: 00607915136659
• UDI-Public: (01)00607915136659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: CFF75
• Device Catalogue Number: 101471079
• Device Lot Number: 1558064
• 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: 03/19/2026
• Initial Report FDA Received Date: 03/25/2026
• 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: GRASPING FORCEPS, SUCTION DEVICE, AND STAPLER
• Patient Sex: Unknown