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

Model Number	CTR73
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: robotic-assisted esophagectomy.Event description: during the surgery, the trocar 12mm port broke into right pleural cavity into what the team felt was 4 pieces/shards.3 pieces/shards were located with 1 potential shard left in the patient likely causing no harm.Imaging completed with no location of a remaining shard.Device failed (e.G.Broke, couldn't get it to work or stopped working).Patient status: no patient injury indicated.The date of the event is unknown.
Additional Manufacturer Narrative
The event unit is not being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided 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: 50009485
• Report Number: 2027111-2026-00664
• Device Sequence Number: 14900745
• Product Code: GCJ
• UDI-Device Identifier: 00607915123680
• UDI-Public: (01)00607915123680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 1577016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 01/20/2026
• 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: Female