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

Model Number	CTF73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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: lap adrenalectomy event description: description ¿ surgeon completed case in prone position and upon pulling out the trocar, the trocar sleeve broke in half leaving have in the skin level of the patient.The full piece was able to be retrieved easily with no harm to patient at end of procedure.The nurse saved the pieces for return and have been placed in office in a biohazard bag.Please send label to [name] who is copied on this email and she will assist in the return of the broken trocar.Additional information provided by applied medical representative on 27aug2024 via email: trocar was inserted in standard 10/2 fashion with obturator in place with no problems.No difficulty during insertion.The break was considered a clean break.Trocar was not used with a robot.Obturator was not inserted in the cannula at the time of the incident.Intervention: the full piece was able to be retrieved easily with no harm to patient at end of procedure.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula shaft.The wall thickness of the cannula shaft near the fracture was measured and did not meet specifications.Based on the condition of the returned unit, it is likely that the reported event was due to the cannula being more susceptible to fracture.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.
Event or Problem Description
Procedure performed: lap adrenalectomy.Event description: description: surgeon completed case in prone position and upon pulling out the trocar, the trocar sleeve broke in half leaving have in the skin level of the patient.The full piece was able to be retrieved easily with no harm to patient at end of procedure.The nurse saved the pieces for return and have been placed in office in a biohazard bag.Please send label to [name] who is copied on this email and she will assist in the return of the broken trocar.Additional information provided by applied medical representative on 27aug2024 via email: trocar was inserted in standard 10/2 fashion with obturator in place with no problems.No difficulty during insertion.The break was considered a clean break.Trocar was not used with a robot.Obturator was not inserted in the cannula at the time of the incident.Intervention: the full piece was able to be retrieved easily with no harm to patient at end of procedure.Patient status: no patient injury.

• 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: 20273790
• Report Number: 2027111-2024-00840
• Device Sequence Number: 17970829
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 101219101
• Device Lot Number: 1519892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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