MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF73
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni event description: information received by customer, via email, on 11feb26: yesterday one of your products, endoport 12mm kii fios 12x100 ctf73, was used on an operation and without anyone noticing from the beginning, the top of the troaker broke.(see picture) the deviation states the following: "a laparoscopic operation is performed.A kii port (12x100) is set in connection with the start of the operation.At the end of the operation, when the specimen is to be removed, the operator notices a callus stuck in the fascia.The operator removes the tip of the plastic troaker (kii port) from the fascia that has broken in connection with the kii gate was set.Photo-documenting the broken kii gate." neither the port nor the packaging has been saved and therefore it cannot be traced to any particular batch, which is a shame.[case considered npr] intervention: the operator removes the tip of the plastic troaker (kii port) from the fascia that has broken in connection with the kii gate was set.Patient status: no patient injury or illness reported.
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 FIOS FIRST ENTRY
• 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: 24384381
• Report Number: 2027111-2026-00381
• Device Sequence Number: 10257637
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K041795
• 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): 02/18/2026

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: CTF73
• 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: 02/11/2026
• Initial Report FDA Received Date: 02/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown