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

Model Number	CTF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic endometriosis ablation.Event description: the trocar was being used for umbilical entry.Before gaining access into the abdomen, the tip of the obturator appeared to shatter within the abdominal wall layers prior to gaining full entry.All fragments of the obturator were removed from the patient.Additional information received from an applied medical representative via email on 25jun25: the standard trocar insertion technique i use involves rotation in alternating clockwise and counterclockwise directions, and this was the method employed at the time of entry.In this instance, the issue arose because the trocar became jammed inside the port.When it was removed¿at the umbilical incision and not while inside the pelvic cavity¿it required more force than usual, resulting in the trocar breaking.While this occurred outside of the pelvic cavity but at the umbilical incision, we cannot definitively exclude the possibility that a small fragment may have been retained intra-abdominally.The break was not a clean break but partially broken/cracked.The trocar as not used with a robot.Intervention: the device was replaced with the same model trocar and no issues were reported and the procedure was completed.Patient status: patient is well - no injury has occurred.
Event or Problem Description
Procedure performed: laparoscopic endometriosis ablation.Event description: the trocar was being used for umbilical entry.Before gaining access into the abdomen, the tip of the obturator appeared to shatter within the abdominal wall layers prior to gaining full entry.All fragments of the obturator were removed from the patient.Additional information received from an applied medical representative via email on 25jun25: the standard trocar insertion technique i use involves rotation in alternating clockwise and counterclockwise directions, and this was the method employed at the time of entry.In this instance, the issue arose because the trocar became jammed inside the port.When it was removed¿at the umbilical incision and not while inside the pelvic cavity¿it required more force than usual, resulting in the trocar breaking.While this occurred outside of the pelvic cavity but at the umbilical incision, we cannot definitively exclude the possibility that a small fragment may have been retained intra-abdominally.The break was not a clean break but partially broken/cracked.The trocar as not used with a robot.Additional information received from an applied medical representative via email on 10jul25: the tm had spoken with the customer and no images were taken and the broken trocar was unfortunately disposed of.Intervention: the device was replaced with the same model trocar and no issues were reported and the procedure was completed.Patient status: patient is well - no injury has occurred.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing 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 documentations were identified.

• 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: 22342139
• Report Number: 2027111-2025-00608
• Device Sequence Number: 21122236
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: CTF33
• Device Catalogue Number: 101476488
• Device Lot Number: 1549400
• Was Device Available for Evaluation?: No
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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