MAUDE Adverse Event Report: Applied Medical Resources Kii OPTICAL ACCESS SYSTEM; Laparoscope, General & Plastic Surgery

Model Number	CTR73
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic appendectomy.Event description: (b)(4) operating room submitting a product problem log.On (b)(6), during a laparoscopic case, access system ref#(b)(4) trocar came apart during use.The clear circular piece was retrieved without incident.Picture attached and product saved.Surgeon, dr."[name]", would like to be contacted by rep.Risk management would also like a follow up.Additional information provided by applied medical representative via email on 13aug2026: thank you very much for letting me know.I was actually on site yesterday speaking with dr."[name]", however i was unaware that dr."[name]" experienced an issue.I am glad to hear that the patient is doing well.I will find out when he is on the schedule next and make sure to come in and speak with him.Thank you for making me aware.If you could, please put me in touch with the risk management team, i will absolutely reach out to them as well.Thank you for your time.Additional information provided by nurse from the facility via email on 17aug2026: the piece fell into the abdomen and was successfully retrieved from the patient.No instrumentation passed through the event unit during the procedure.No internal seal components were removed or cut to inspect the damaged component.Intervention: item removed from abdomen case resolved without further incident.Patient status: no clinical impact.The 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.

• 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 ; +1(949)713-5359
• MDR Report Key: 50524769
• Report Number: 2027111-2026-00704
• Device Sequence Number: 6050868
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 1588372
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 03/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown