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

Model Number	CTR73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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: thoracic procedure with wedge resection.Event description: model #: ctr73.Lot #: unk.The procedure was a thoracic procedure with wedge resection.The surgeon inserted the trocar with excessive force.The cannula broke but was not noticed until the end.The procedure was completed with broken trocar, and the surgeon did not know the trocar was broken until he put a camera in at the end.The trocar broke in one piece.The broken piece was retrieved from the patient.Additional information obtained from account manager via email on (b)(6)2025: there was difficulty during insertion, because the surgeon did not rotate the trocar.He simply used blunt downward force in a very narrow space.The trocar was not used with a robot.The obturator was inserted in the cannula at the same time of the incident.Intervention: completed procedure with broken trocar, the surgeon did not know the trocar was broken until he put a camera in at the end.Patient status: patient is ok.
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 cannula wall thickness near the fracture location was measured and did not meet specifications.Based on the condition of the returned unit and the description of the event, it is likely that the reported event may have occurred during insertion as the customer did not rotate the trocar when inserting.It is likely that the cannula shaft fracture was more susceptible to fracture.However, the exact root cause could not be determined.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.
Event or Problem Description
Procedure performed: thoracic procedure with wedge resection.Event description: model #: ctr73.Lot #: unk.The procedure was a thoracic procedure with wedge resection.The surgeon inserted the trocar with excessive force.The cannula broke but was not noticed until the end.The procedure was completed with broken trocar, and the surgeon did not know the trocar was broken until he put a camera in at the end.The trocar broke in one piece.The broken piece was retrieved from the patient.Additional information obtained from account manager via email on 27jan2025: there was difficulty during insertion, because the surgeon did not rotate the trocar.He simply used blunt downward force in a very narrow space.The trocar was not used with a robot.The obturator was inserted in the cannula at the same time of the incident.Intervention: completed procedure with broken trocar, the surgeon did not know the trocar was broken until he put a camera in at the end.Patient status: patient is ok.

• Brand Name: KII OPTICAL 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: 21322692
• Report Number: 2027111-2025-00344
• Device Sequence Number: 15574601
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: CTR73
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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