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

Model Number	CTF73
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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: hernia event description: during insertion of a flexible prosthetic mesh using a fenestrated laparoscopy jaw in this trocar, for inguinal wall reinforcement, several parts of the valve have become separated and finish in the abdominal cavity of the patient.Additional information received from applied medical representative via email on 28feb25: not all the broken parts were retrieved from the patient¿s abdomen.Additional information received from applied medical representative via email on 10mar25: the part concerning is the white part of the seal in french ¿la collerette blanche¿.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: hernia.Event description: during insertion of a flexible prosthetic mesh using a fenestrated laparoscopy jaw in this trocar, for inguinal wall reinforcement, several parts of the valve have become separated and finish in the abdominal cavity of the patient.Additional information received from applied medical representative via email on 28feb25: not all the broken parts were retrieved from the patient¿s abdomen.Additional information received from applied medical representative via email on 10mar25: the part concerning is the white part of the seal in french ¿la collerette blanche¿.According to the patient's file, he is doing well after the operation.No infectious context cited.They can¿t confirm if any pieces fall into the patient.Additional information received from applied medical representative via email on 13may25: some white part of the seal fell.No internal seal components removed or cut to inspect the damaged component.Additional information received from applied medical representative via email on 16may25: according to the pharmacist it wasn¿t the entire part of the component that falls but only a part.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component and a black fragment.Visual inspection confirmed the complainant¿s experience of shield dislodgment and seal fragmentation.The clear component was identified as a shield and the black fragment was identified as the septum ¿ both internal components of the seal.Based on the condition of the returned unit and description of the event, it is likely the shield dislodgment and damaged septum was caused by the non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical¿s ifu states ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing¿.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: 21560840
• Report Number: 2027111-2025-00407
• Device Sequence Number: 9215861
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 1540839
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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: WINDOW CLAMP
• Patient Sex: Unknown