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

Model Number	CTR22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: transoral endoscopic right thyroid lobectomy and isthmusectomy, vestibular approach.Intraoperative ultrasound of the thyroid and neck for surgical planning.Fiberoptic laryngoscopy.Event description: two trocars used during case both with same lot number defective.First trocar broke in two pieces when being placed.Both pieces retrieved and able to be placed together to verify no missing pieces.Second trocar from same lot number also disformed and created a problem causing difficulty advancing instrument through.Both trocars from lot 1522399 ref #(b)(4).Two additional trocars opened with different lot numbers that functioned as expected.Additional information provided by [hospital representative] on (b)(6) 2026 (entered by applied medical representative): as i was not involved in the case i have very few additional details to add.Event date-1/2/2026.There was no patient injury.There were two device w/ issues.#1 broke into two pieces and was retrieved.#2 - same lot # - deformed and difficult to advance.Device was changed out for a different lot # and functioned as expected.Intervention: two additional trocars opened with different lot numbers that functioned as expected.Patient status: no patient injury indicated.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the event unit, it is difficult to determine if the reported event was caused by a device non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.This report is to follow up medwatch report # (b)(4).
Event or Problem Description
Procedure performed: transoral endoscopic right thyroid lobectomy and isthmusectomy, vestibular approach.Intraoperative ultrasound of the thyroid and neck for surgical planning.Fiberoptic laryngoscopy.Event description: two trocars used during case both with same lot number defective.First trocar broke in two pieces when being placed.Both pieces retrieved and able to be placed together to verify no missing pieces.Second trocar from same lot number also disformed and created a problem causing difficulty advancing instrument through.Both trocars from lot 1522399 ref #(b)(4).Two additional trocars opened with different lot numbers that functioned as expected.Additional information provided by [hospital representative] on 23feb2026 (entered by applied medical representative): as i was not involved in the case i have very few additional details to add.Event date-1/2/2026 there was no patient injury.There were two device w/ issues #1 broke into two pieces and was retrieved #2 -same lot # -deformed and difficult to advance.Device was changed out for a different lot # and functioned as expected.Additional information provided by [hospital representative] on 04mar2026 (entered by applied medical representative): that information is incorrect.The packaging is available however, the devices were discarded.Intervention: two additional trocars opened with different lot numbers that functioned as expected.Patient status: no patient injury indicated.

• Brand Name: KII LOW PROFILE 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: 24565216
• Report Number: 2027111-2026-00431
• Device Sequence Number: 15785678
• Product Code: GCJ
• UDI-Device Identifier: 00607915126506
• UDI-Public: (01)00607915126506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: CTR22
• Device Catalogue Number: 101179901
• Device Lot Number: 1522399
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/11/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 59 KG