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

Model Number	CTF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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 & liver wedge resection.Event description: reinserted into abdomen after it has been removed and upon re-entry the tip of the cannula had chipped off.Additional information received from an applied medical representative via email on 09may25: event date of 10apr25, name of procedure laparoscopic cholecystectomy & liver wedge resection.The trocar was inserted with mostly clockwise rotation with no difficulty during insertion.It was stated that the break was considered a clean break and unknown if it caused particulation.Likely to be a single piece broken off but unable to recover the piece hence, unsure.Likely a grasper but only noticed the break after it happened.The healthcare user were unable to find the broken piece and it was at the end of the procedure, so they removed the trocar.The trocar was not used with a robot.Intervention: it was the end of the procedure, so we removed the trocar.Patient status: no issues to patient.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy & liver wedge resection.Event description: reinserted into abdomen after it has been removed and upon re-entry the tip of the cannula had chipped off.Additional information received from an applied medical representative via email on 09may25: event date of (b)(6) 2025, name of procedure laparoscopic cholecystectomy & liver wedge resection.Th trocar was inserted with mostly clockwise rotation with no difficulty during insertion.It was stated that the break was considered a clean break and unknown if it caused particulation.Likely to be a single piece broken off but unable to recover the piece hence, unsure.Likely a grasper but only noticed the break after it happened.The healthcare user were unable to find the broken piece and it was at the end of the procedure, so they removed the trocar.The trocar was not used with a robot.Intervention: it was the end of the procedure, so we removed the trocar.Patient status: no issues to patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.Based on the condition of the returned unit, it is possible that the reported event was due to instrumentation coming into contact with the cannula tip during the procedure.However, the exact root cause could not be determined.A historical trend analysis and review of production records was 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: 21997004
• Report Number: 2027111-2025-00522
• Device Sequence Number: 15823821
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041795
• 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): 02/20/2026

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: CTF03
• Device Catalogue Number: 101472912
• Device Lot Number: 1537569
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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: GRASPER
• Patient Sex: Unknown