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

Model Number	CTR73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic thoracic case: event description: during a laparoscopic thoracic procedure, 2 pieces of the trocar broke off inside of the patient.They were able to remove the 2 pieces of plastic.Note from the physician about the performing physician: the surgeon is fairly new to the procedure so it could be user error.The product is expected to return.Type of intervention: replaced with another trocar to finish.Patient status: patient is fine.
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 cannula shaft fracture.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit, it is likely that the reported event was due to uneven wall thickness of the cannula which could cause the cannula to be more susceptible to fracture.It is possible that the cannula placement during the procedure was made it more susceptible to fracture during device manipulation.A historical trend analysis and review of production records was performed and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic thoracic case.Event description: during a laparoscopic thoracic procedure, 2 pieces of the trocar broke off inside of the patient.They were able to remove the 2 pieces of plastic.Note from the physician about the performing physician: the surgeon is fairly new to the procedure so it could be user error.The product is expected to return.Type of intervention: replaced with another trocar to finish.Patient status: patient is fine.

• 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: 20669002
• Report Number: 2027111-2024-00908
• Device Sequence Number: 7238861
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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
• Device Catalogue Number: 101219401
• Device Lot Number: 1516409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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