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: unknown.Event description: the device was used intraop - did not appear to be using excessive force or levering anything and the port broke during the operation.Another one of the same lot number was opened and used to complete the operation (lot 1527761).Additional information was provided as pcf ama territory manager on (b)(6) 2025 surgeon was using trocar as camera port.Surgeon was looking around abdominal cavity as normal when she heard a crack.Surgeon was looking around abdominal cavity as normal when she heard a crack.Reporting surgeon and nurse stated no undue force was being applied, and she was articulating scope as normal.Nil excessive leveraging of the scope.Port cracked in half towards the seal housing as per image.There was no clinical impact to the patient as a result of the event.User removed trocar and replaced with another ctf73 to resolve the situation.Nil issues.Scope in port was the other instrument used when the event occurred.Intervention: user removed trocar and replaced with another ctf73.Nil issues.Another one was opened.Lot number was the same 1527761.Patient status: stable.The date of the event is unknown.
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.
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 relevant documentations were identified.
Event or Problem Description
Procedure: unknown.Event description: the device was used intraop - did not appear to be using excessive force or levering anything and the port broke during the operation.Another one of the same lot number was opened and used to complete the operation (lot 1527761).Additional information was provided as pcf ama territory manager on (b)(6) 2025 surgeon was using trocar as camera port.Surgeon was looking around abdominal cavity as normal when she heard a crack.Surgeon was looking around abdominal cavity as normal when she heard a crack.Reporting surgeon and nurse stated no undue force was being applied, and she was articulating scope as normal.Nil excessive leveraging of the scope.Port cracked in half towards the seal housing as per image.There was no clinical impact to the patient as a result of the event.User removed trocar and replaced with another ctf73 to resolve the situation.Nil issues.Scope in port was the other instrument used when the event occurred.Intervention: user removed trocar and replaced with another ctf73.Nil issues.Another one was opened.Lot number was the same 1527761.Patient status: stable the date of the event is unknown.

• 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: 21265005
• Report Number: 2027111-2025-00335
• Device Sequence Number: 18526361
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: 101478837
• Device Lot Number: 1527761
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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