MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII SHIELDED BLADED ACCESS SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB73
Medical Device Problem Code	Fracture (1260)
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: thoracoscopy robot.Event description: customer says that trocar broke in the patient.Additional information request from an applied medical representative via email on 28feb2025: there was no patient injury and the patient is fine.The device was used during thoracoscopy robot.No photos available.Trocar placement every thing was good but when surgeon wants to introduce the camera he saw that the trocar was broke in two pieces.Inferior part of the trocar broke and the break did not cause particulation.The trocar was inserted via intercostal with no difficulty insertion.The obturator was inserted in the cannula at the time of the incident.Patient status: fine.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula shaft break.The cannula wall thickness near the fracture location was measured and did not meet specifications.Based on the condition of the returned unit and description of the event, it is possible the reported event was due to uneven wall thickness of the cannula and/or forces exerted on the cannula during the procedure.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: thoracoscopy robot.Event description: customer says that trocar broke in the patient.Additional information request from an applied medical representative via email on 28feb2025: there was no patient injury and the patient is fine the device was used during thoracoscopy robot no photos available.Trocar placement everything was good but when surgeon wants to introduce the camera, he saw that the trocar was broke in two pieces.Inferior part of the trocar broke and the break did not cause particulation.The trocar was inserted via intercostal with no difficulty insertion.The obturator was inserted in the cannula at the time of the incident.Patient status: fine.

• Brand Name: KII SHIELDED BLADED ACCESS SYSTEM
• 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: 21516370
• Report Number: 2027111-2025-00394
• Device Sequence Number: 9584619
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: CTB73
• Device Catalogue Number: 101476486
• Device Lot Number: 1537519
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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