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

Model Number	CTF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the fios was used with the camera to make the first entry.Upon removal, they noticed that the tip had fractured and fragmented.Fragments were not retrieved from the patient.The hospital is performing an internal investigation.Additional information provided by applied medical representative on 20nov2025: at the beginning of the case the physician was inserting without rotation and then halfway through inserting trocar they started alternating clockwise and counterclockwise.This trocar was not used with a robot.Yes, the obturator was inserted in the cannula at the time of the incident.Intervention: the tip had fragmented and pieces were reportedly left behind in the patient; they could not locate it; they proceeded with the case.Patient status: fragments were not retrieved from the patient but patient is okay.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured obturator tip.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: the fios was used with the camera to make the first entry.Upon removal, they noticed that the tip had fractured and fragmented.Fragments were not retrieved from the patient.The hospital is performing an internal investigation.Additional information provided by applied medical representative on 20nov2025: at the beginning of the case the physician was inserting without rotation and then halfway through inserting trocar they started alternating clockwise and counterclockwise.This trocar was not used with a robot.Yes the obturator was inserted in the cannula at the time of the incident.Medwatch received from fda on 18dec2025 via email: while trying to insert laparoscopic trocar via invisalign, the end of the trocar/obturator broke off.Intervention: the tip had fragmented and pieces were reportedly left behind in the patient; they could not locate it, they proceeded with the case.Patient status: fragments were not retrieved from the patient but patient is okay.

• 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: 23623053
• Report Number: 2027111-2025-00883
• Device Sequence Number: 21100383
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: CTF03
• Device Catalogue Number: 101478835
• Device Lot Number: 1561396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MM TROCARS X4.
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Race: White