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

Model Number	CTR01
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 performed: unknown event description: the procedure started and the surgeon began to insert the trocars for the procedure.All of the trocars were placed and the surgeon began to insert the graspers.While inserting the grasper and moving the trocar, nursing staff and the surgeon heard a pop and realized that the trocar had broke in half.The portion of the trocar that was outside of the patient was removed and the surgeon began to work to get the other half of the trocar out.The other half of the trocar was retrieved using hemostats.Another trocar was inserted in a different location and the surgery proceeded.No other therapies were used on the patient at the time of the event that may have caused or contributed to the event.The date of event is unknown but it occurred in may 2024.Concomitant devices: grasper, hemostat.Intervention: another trocar was inserted in a different location and the surgery proceeded.Patient status: no patient injury.
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 not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.[correction] sections d1 (primary unique device identification number) has been updated.
Event or Problem Description
Procedure performed: unknown.Event description: the procedure started and the surgeon began to insert the trocars for the procedure.All of the trocars were placed and the surgeon began to insert the graspers.While inserting the grasper and moving the trocar, nursing staff and the surgeon heard a pop and realized that the trocar had broke in half.The portion of the trocar that was outside of the patient was removed and the surgeon began to work to get the other half of the trocar out.The other half of the trocar was retrieved using hemostats.Another trocar was inserted in a different location and the surgery proceeded.No other therapies were used on the patient at the time of the event that may have caused or contributed to the event.The date of event is unknown but it occurred in (b)(6) 2024.Concomitant devices: grasper, hemostat.Intervention: another trocar was inserted in a different location and the surgery proceeded.Patient status: no patient injury.

• 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 ; 9497138710
• MDR Report Key: 20348571
• Report Number: 2027111-2024-00854
• Device Sequence Number: 15435496
• Product Code: GCJ
• UDI-Device Identifier: 00607915124045
• UDI-Public: (01)00607915124045
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: CTR01
• Was Device Available for Evaluation?: No
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown