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

Model Number	CFF33
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: anterior mediastinal biopsy - thoracic surgery.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The trocars were inserted and the balloon inflated as usual.No specific action identified as the possible cause to the incident.It was used 2 cff33 (videoscope and instrument) and 1 cff03 (instrument) for this procedure.During the procedure the surgeon realized there was a plastic piece inside the patient.After an inspection, they concluded it was a plastic fragment from the tip of a cff33.It was removed and they continued with the surgery.At the end of the surgery, they realized both cff33 were cracked longitudinally, not only the broken one.Cff03 was ok.According to the surgeon, the patient was very obese and had a lot of muscular contractions during the procedure.They used the trocars until the end of the surgery.No additional intervention was required.Additional information received from an applied medical representative via email on 21feb2025: the trocar was inserted with rotation as they usually do with no difficulty during insertion.The break did not cause particulation only in one piece and the piece was retrieved from the patient as soon as they realized it was broken.It was not used with a robot.They can't identify the time of the incident.They didn't notice any different until they saw the broken piece.Intervention: they used the trocar until the end of the surgery.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: anterior mediastinal biopsy: thoracic surgery.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).The trocars were inserted and the balloon inflated as usual.No specific action identified as the possible cause to the incident.It was used 2 cff33 (videoscope and instrument) and 1 cff03 (instrument) for this procedure.During the procedure the surgeon realized there was a plastic piece inside the patient.After an inspection, they concluded it was a plastic fragment from the tip of a cff33.It was removed and they continued with the surgery.At the end of the surgery, they realized both cff33 were cracked longitudinally, not only the broken one.Cff03 was ok.According to the surgeon, the patient was very obese and had a lot of muscular contractions during the procedure.They used the trocars until the end of the surgery.No additional intervention was required.Additional information received from an applied medical representative via email on 21feb2025: the trocar was inserted with rotation as they usually do with no difficulty during insertion.The break did not cause particulation only in one piece and the piece was retrieved from the patient as soon as they realized it was broken.It was not used with a robot.They can't identify the time of the incident.They didn't notice any different until they saw the broken piece.Additional information received from an applied medical representative via email on 30apr2025: there are no images for these two linked complaints and he has talked again tot eh main doctor and after analysing the recorded video she said it;s not visible or perceptible in the video the time the event occurred.Intervention: they used the trocar until the end of the surgery.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and 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 trends 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: 21464855
• Report Number: 2027111-2025-00384
• Device Sequence Number: 3518808
• 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): 06/25/2025

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: 1532809
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REGULAR LAPAROSCOPIC INSTRUMENTS
• Patient Sex: Unknown