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

Model Number	CFF03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: removal of an ovarian cyst ¿ excision of a teratoma in the adnexal region.Event description: as normal.It was discovered at the very end.It is the plastic part on the inside of the seal housing.At the end of the operation, the surgeon/assistant accidentally discovered a small piece of plastic.They removed it and eventually identified its source.It is uncertain when the plastic piece detached from the trocar.There had been no issues with the trocar during surgery ¿ the instruments passed in and out normally, and there was no abnormal gas leakage.The piece of plastic was removed, and the operation was completed as normal.Additional information received from applied medical representative via email on 09oct25: images attached.The piece was clear in color.The equipment that has been used through the trocars includes: grasping forceps, suction/irrigation device, disposable puncture needle, and thunderbeat.No internal seal components removed or cut to inspect the damaged component.Additional information received from applied medical representative via email on 10oct25: yes.That is the plastic piece that is the reason for this complaint.Intervention: the piece of plastic was removed, and the operation was completed as normal.Patient status: no complications for the patient.
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.
Event or Problem Description
Procedure performed: removal of an ovarian cyst ¿ excision of a teratoma in the adnexal region.Event description: as normal.It was discovered at the very end.It is the plastic part on the inside of the seal housing.At the end of the operation, the surgeon/assistant accidentally discovered a small piece of plastic.They removed it and eventually identified its source.It is uncertain when the plastic piece detached from the trocar.There had been no issues with the trocar during surgery ¿ the instruments passed in and out normally, and there was no abnormal gas leakage.The piece of plastic was removed, and the operation was completed as normal.Additional information received from applied medical representative via email on 09oct25: images attached.The piece was clear in color.The equipment that has been used through the trocars includes: grasping forceps, suction/irrigation device, disposable puncture needle, and thunderbeat.No internal seal components removed or cut to inspect the damaged component.Additional information received from applied medical representative via email on 10oct25: yes.That is the plastic piece that is the reason for this complaint.Intervention: the piece of plastic was removed, and the operation was completed as normal.Patient status: no complications for the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complainant¿s experience of seal component dislodgment.Based on the description of the event and the condition of the returned unit, it is likely the reported event was caused by an asymmetrical instrument that was inserted through the trocar in a non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ 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: 23338476
• Report Number: 2027111-2025-00811
• Device Sequence Number: 7957398
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: CFF03
• Device Catalogue Number: 101473818
• Device Lot Number: 1554057
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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: DISPOSABLE PUNCTURE NEEDLE; GRASPING FORCEPS AND SUCTION IRRIGATION
• Patient Sex: Unknown