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

Model Number	CTB73
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: unk.Event description: circumstances/description of the incident: the trocar was deformed at the distal end (tip), which caused injury to the patient's rib upon insertion of the trocar.Clinical findings: rib injury.Precautionary measures and actions taken: trocar replacement.Additional information received by an applied medical rep via email on 28jul2026: i didn't manage to get any information last week, i'll try again this week.Patient status: unk.
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.This report serves as initial report for complaint: (b)(4).

• Brand Name: Kii Shielded Bladed Access System
• Common Device Name: Laparoscope, General & Plastic Surgery
• Manufacturer (Section D): Applied Medical Resources; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): 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: 50183114
• Report Number: 2027111-2026-01729
• Device Sequence Number: 18613466
• Product Code: GCJ
• UDI-Device Identifier: 00607915123727
• UDI-Public: (01)00607915123727
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CTB73
• Device Catalogue Number: CTB73
• Device Lot Number: 1575493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 12/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown