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)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: i would like to raise an issue with one of your ports that you supply, ctf73, lot number 1541793, that unfortunately snapped during a procedure.I was wondering if you had any other issues with this product patient status: no patient injury or illness was reported.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula shaft fracture.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit and description of the event, it is possible that the reported event was due to uneven wall thickness of the cannula and/or forces exerted on the cannula during the procedure.A historical trend analysis and review of production records was performed and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic nephrectomy.Event description: i would like to raise an issue with one of your ports that you supply, ctf73, lot number 1541793, that unfortunately snapped during a procedure.I was wondering if you had any other issues with this product.Additional information received from the hospital via email on 12may25: duplicate search was performed and it was found to be a similar incident to this complaint.Confirmed this with the healthcare person stated in the email.Additional information received from the customer via email on 20may25: no patient was injured and the patient was under anaesthetic at the time.Event date was updated to 28apr25.The procedure was a laparoscopic nephrectomy.It was during used that it snapped and the port was inserted by rotation.It snapped in half, so in 2 pieces and we believe we retrieved all pieces.A robot was not used at all.The [brand redacted] device was in use at the time.Unsure at the moment if the device is returning for investigation.Additional information received from the customer via email on 21may25: confirmation device is returning.Nca submitted a report via email on 21may25: mhra reference number 2025/005/012/501/009.Duplicate search was performed and it was found to be this complaint.Shortly after inserting a 12mm port, (lot no:1541793) into a patient's abdomen, the port snapped in half.No excessive force was being used at the time, as we were still inserting other ports at the time.The broken end fell into the abdomen.Port was removed under vision.Visually inspected to check at all parts were removed.We are happy all parts are out of the abdomen.Patient status: no patient was injured.

• 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: 21996827
• Report Number: 2027111-2025-00521
• Device Sequence Number: 8769742
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 1541793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HARMONIC DEVICE.
• Patient Sex: Unknown