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

Model Number	CTF73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap unilateral salpingoopherctomy and omentbiopsy.Event description: information received by an applied medical representative, via email, on 17-feb-26: new similar incident on (b)(6).Today the tip of trocar broke.[name redacted] has taken this box out of storage as she is ¿certain¿ that the previous trocar came from the same box.She will return the trocar from todays event.Additional information received by an applied medical representative, via emails, on 20-feb-26: we asked the customer to open one sterile trocar that haven't been used and it will be returning as well; i sent some pictures earlier today.We will of course send them a new one for this.No patient injury, plastics were found preoperative, and to their knowledge no pieces left in the abdomen.Patient status is well.The plastic was discovered and removed.Procedure was lap unilateral salpingoopherctomy and omentbiopsy.The break was identified after use, during inspection.All pieces were retrieved from customer.The trocar was not used with a robot.Expected products returning: 1 unit used in the surgery (event unit); 1 unit not used in the surgery but non-sterile; unknown quantity of sterile units.Additional information received by an applied medical representative via email on 25-feb-26: it's two trocars returning in that complaint.One is used and involved in the claim reported.The second is one that me and my manager asked them to open, so two non-sterile trocars is returning.Intervention: plastic was discovered and removed.Patient status: no patient injury or illness was reported.
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 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: 24524582
• Report Number: 2027111-2026-00418
• Device Sequence Number: 21263413
• 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): 03/05/2026

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
• Device Catalogue Number: 101472325
• Device Lot Number: 1574167
• 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: 02/17/2026
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 11/24/2025
• 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