MAUDE Adverse Event Report: Applied Medical Resources Kii Optical Access System; Laparoscope, General & Plastic Surgery

Model Number	C0R37
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	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vats lobectomie.Event description: pcf was received with few information: how the device was being used is unknown.The description of the event is unknown.There is no clinical impact to the patient.Additional information received by an applied medical representative via email on 20aug26: the product was used in the same way i observed before.They use rolled-up gauze during the procedure it insert and remove it through the trocar.I did not receive a photo of the product.It was ordered via hospital logistics, account id (b)(4) - lot confirmation was performed with this account.Additional information by an applied medical representative, via email on 21aug26: the duck was in total released from the trocar.Closing letter requested.Intervention: removing the double duck bill out of the patient.Patient status: ok.
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: 50525350
• Report Number: 2027111-2026-00705
• Device Sequence Number: 6012483
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1576815
• 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: 08/17/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 12/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Intuitive robot laparoscopic instruments; Rolled-up gauze
• Patient Sex: Unknown