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

Model Number	CFF05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
The event date is unknown.Procedure performed: unknown.Event description: a small part of the plastic port broke off.Patient status: no patient harm to the patient has been reported.
Event or Problem Description
The event date is unknown.Procedure performed: laparoscopic appendectomy event description: a small part of the plastic port broke off.Additional information received by applied medical rep via email on 22nov24: the break occurred on the tip during use.The trocar was inserted with the correct rotation.There was difficulty during insertion.Clean break.The piece was retrieved from the patient.No robot.Additional information received by applied medical rep via email on 2dec24: the code and lot number was given to me by the theatre coordinator via email and when i collected the product it was sealed in a bag and bloody so i did not open it to confirm the correct code unfortunately.They must have made a mistake when they initially sent me the code.If you look at the original photos that were sent it looks like the cff05.Intervention: device replacement patient status: no patient harm to the patient has been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is possible that the fractured cannula was caused by excessive force exerted on the cannula tip during the insertion.However, 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.[correction] sections d1 (primary unique device identification number), d4 (additional unique device identification number, model, catalog and lot), and g4 (pma/510(k) number) have been updated.

• 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: 20636496
• Report Number: 2027111-2024-00899
• Device Sequence Number: 12604323
• Product Code: GCJ
• UDI-Device Identifier: 00607915123123
• UDI-Public: (01)00607915123123
• 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): 05/06/2025

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: CFF05
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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: LAP INSTRUMENT
• Patient Sex: Unknown