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	11/26/2025
Type of Reportable Event	Malfunction
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: laparoscopic cholecystectomy event description: the surgeon wanted to drain bile from the gall bladder to make it easier to manipulate during surgery.He inserted an aspiration needle down the port which then started to leak, therefore, we changed it for a new one.It wasn¿t until we were removing the ports towards the end of the procedure that the surgeon noticed the clear plastic piece inside the patient.No harm occurred as it was then removed.Additional information and photos received by an applied medical representative via email on 01dec25: lot number updated accordingly.Lot trace performed with nhs supply chain account under id (b)(6).Additional information and received by an applied medical representative via email on 02dec25: no issues with patient as a result.The user resolved the situation by removing plastic piece during procedure.Event happened midway in the procedure, as the consultant wanted to drain bile from the gallbladder prior to removal.Pieces fell into the patient and all were retrieved.Ablation needle was being used at the time of the incident.Additional information and received by an applied medical representative via email on 03dec25: the instruments used prior to the incident were reuseable johann laparoscopic forceps.We have not removed or cut anything on the internal seal to inspect the damaged component.Intervention: changed it for a new one and removed plastic piece during procedure.Patient status: no issues with patient as a result.

• 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: 23832762
• Report Number: 2027111-2025-00922
• Device Sequence Number: 12032272
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/06/2026

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: 1560778
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REUSEABLE JOHANN LAPAROSCOPIC FORCEPS; WALL ASPIRATION NEEDLE
• Patient Sex: Unknown