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

Model Number	CTR01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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: unknown event description: i wanted to reach out and let you know that there was an issue in the or this week with one of the applies trocars.(b)(6) 2024 a doctor broke a applies kii optical trocar off in a patient.At this time, i do not have a reference number to provide.I do have the actual trocar.A medwatch form was filled out and sent in.Additional information provided by applied medical representative via email on 01nov2024: the patient is fine.It sounds like the bend/break occurred at the shaft."the trocar broke inside the patient; it was a clean cut." it is unclear that if the shaft broke, the obturator inside the cannula at the time of the incident.The number(s) of cannulas that were inserted using the obturator prior to the incident is unclear.The bend/break occurred during use.It is unclear how the trocar inserted through the tissue layers.Intervention: unknown.Patient status: patient is 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 fracture.Based on the condition of the returned unit, it is possible that the reported event was caused by force exerted on the cannula during insertion.However, applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no documentations were identified.
Event or Problem Description
Procedure performed: unknown.Event description: i wanted to reach out and let you know that there was an issue in the operating room this week with one of the applies trocars.10/23 a doctor broke an applies kii optical trocar off in a patient.At this time, i do not have a reference number to provide.I do have the actual trocar.A medwatch form was filled out and sent in.Additional information provided by applied medical representative via email on 01nov2024: the patient is fine.It sounds like the bend/break occurred at the shaft."the trocar broke inside the patient; it was a clean cut." it is unclear that if the shaft broke, the obturator inside the cannula at the time of the incident.The number(s) of cannulas that were inserted using the obturator prior to the incident is unclear.The bend/break occurred during use.It is unclear how the trocar inserted through the tissue layers.Additional information obtained from user facility, medwatch #mw5161804 via email: trocar broke in half inside of patient.Surgeon putting in trocar and while inserting it she needed to use a little pressure.Trocar broke in half and stay in fascia.General surgery came to assist and both pieces were removed.Intervention: general surgery came to assist and both pieces were removed.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: 20713885
• Report Number: 2027111-2024-00917
• Device Sequence Number: 9903617
• Product Code: GCJ
• UDI-Device Identifier: 00607915124045
• UDI-Public: (01)00607915124045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 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: CTR01
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 05/06/2025
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Race: Black Or African American