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	11/07/2024
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: cholecystectomy.Event description: surgeon is not sure when the event had been done but he saw a particle of cannula in the patient stomach then check the edge of trocars by camera and found the broken trocar.Type of intervention: changing the trocar.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: cholecystectomy.Event description: surgeon is not sure when the event had been done but he saw a particle of cannula in the patient stomach then check the edge of trocars by camera and found the broken trocar.Type of intervention: changing the trocar.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula tip.Based on the event description and similar events, it is likely that the cannula tip fracture was due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.A historical trend analysis and review of production records were performed and no relevant documentation was 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: 20789731
• Report Number: 2027111-2024-00927
• Device Sequence Number: 7895230
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1508409
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• 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: GRASPER, VOYANT
• Patient Sex: Unknown