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

Model Number	CTR03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: we use your laparoscopic trocars.A ctr03 was being used on an case and the sleeve bent/trocar snapped in half.Lot: 1573129 exp:2028-12-16.All pieces retrieved.No harm to patient.I have the faulty trocar.I look forward to hearing from you.Additional information provided by [user facility representative] on 14apr2026: i have the trocar and original package for return.Bend/break occurred at shaft.The bend/break was identified during insertion.The trocar was not used with a robot.Yes, the obturator was inserted in the cannula at the time of the incident picture provided.Additional information provided by [user facility representative] on 16apr2026: the trocar was the 3rd trocar of the case.The 1st 2 went in without issues.The scrub did not notice any unusual behavior prior to the trocar just snapping.Intervention: they removed the broken part and used a different trocar and sleeve.Patient status: stable.
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 ; 9497135359
• MDR Report Key: 24990233
• Report Number: 2027111-2026-00517
• Device Sequence Number: 9300515
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: CTR03
• Device Catalogue Number: 101478496
• Device Lot Number: 1573129
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 12/17/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown