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

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: ni.Event description: under insertion, the tip of the obturator broke off into several pieces.Additional information received by an applied medical representative via email on 28nov2025: the end of the trocar fragmented/cracked in several pieces during insertion.The abdomen was already insufflated with co2 using verses needle prior to the trocar insertion.There had been some force involved in getting it through the abdomen, but according to the surgical nurse, not enough for something like this to happen.She didn't say anything about the specific insertion method for the trocar.They had opened a second trocar that they used during the procedure, but when they applied light pressure on the end of it after it had been removed/after the operation, it also fragmented into several pieces like the first one (which is why a complaint has also been made about this trocar).No pieces fell into the patient and no harm was done as a result of the incident.Intervention: opened a second trocar.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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complaint¿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 trends were identified.
Event or Problem Description
Procedure performed: ni.Event description: under insertion, the tip of the obturator broke off into several pieces.Additional information received by an applied medical representative via email on (b)(6) 2025: the end of the trocar fragmented/cracked in several pieces during insertion.The abdomen was already sufflated with co2 using verses needle prior to the trocar insertion.There had been some force involved in getting it through the abdomen, but according to the surgical nurse, not enough for something like this to happen.She didn't say anything about the specific insertion method for the trocar.They had opened a second trocar that they used during the procedure, but when they applied light pressure on the end of it after it had been removed/after the operation, it also fragmented into several pieces like the first one (which is why a complaint has also been made about this trocar).No pieces fell into the patient and no harm was done as a result of the incident.[intervention updated (b)(6) 2025].Additional information received by applied medical representative on (b)(6) 2025: the correct number is ten trocars in total (two non-sterile used during the incident), and eight sterile trocars that they no longer want to use because of the incident (all with the same lot number).- additional information received by applied medical representative on (b)(6) 2025: patient status ok.Procedure being performed: don't know, but they tried to insert it through an umbilical incision.Concomitant devices unknown.As i understood it from the surgical nurse, the second trocar was inserted using an open technique and used during the procedure.The second trocar/obturator did not fragment during use, but after the procedure (when they applied pressure on the tip of it after it had been removed, it also fragmented into several pieces like the first one).Intervention: opened a second trocar.Patient status: no patient injury or illness was reported.

• 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: 23697902
• Report Number: 2027111-2025-00895
• Device Sequence Number: 10288373
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K083638
• 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): 03/31/2026

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1559498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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
• Patient Sex: Unknown