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

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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: endoscopic mitreal valve event description: being used as a port for the scope.Once the procedure had finished the surgeon and registrar noticed that the port was broken at the tip of the cannula.The only instrument used in the port throughout was the scope.The staff did not notice the broken trocar till the port had been removed.They have confirmed that they did not manage to find the fragmented pieces in the patient, but it was not a concern to the patients outcome or recovery.Additional information received from an applied medical representative via email on 16dec24: the trocar was inserted - 10 to 2 twisting motion and no difficulty during insertion.There was no difficulty during insertion.The patient did not have previous surgery at the site.The break did cause particulation.The trocar was not used with a robot.Type of intervention: no device replacement as it was not noticed till the end of the case.Patient status: no injury or death to patient.Patient safe.
Event or Problem Description
Procedure performed: endoscopic mitreal valve.Event description: being used as a port for the scope.Once the procedure had finished the surgeon and registrar noticed that the port was broken at the tip of the cannula.The only instrument used in the port throughout was the scope.The staff did not notice the broken trocar till the port had been removed.They have confirmed that they did not manage to find the fragmented pieces in the patient, but it was not a concern to the patients outcome or recovery.Additional information received from an applied medical representative via email on 16dec24: the trocar was inserted - 10 to 2 twisting motion and no difficulty during insertion.There was no difficulty during insertion.The patient did not have previous surgery at the site.The break did cause particulation.The trocar was not used with a robot.Type of intervention: no device replacement as it was not noticed till the end of the case.Patient status: no injury or death to patient.Patient safe.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The cannula tip was missing a fragment.Based on the condition of the returned unit, it is likely that the cannula tip fractured was due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.Applied medical has performed a historical trend analysis and review of production records was performed and no relevant documentation was 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: 21074399
• Report Number: 2027111-2025-00303
• Device Sequence Number: 8498269
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1522002
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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
• Patient Sex: Unknown