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

Model Number	CFF73
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	11/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic anterior resection.Event description: procedure was coming to an end and the trocar was removed from the abdomen.The surgeons went back into the abdomen through a different trocar to have a final check and wash out, a fragment of the septum fanned instrument guide had appeared to come off the trocar and was inside the patient.All fragments were collected.Unsure of what action or when the incident occurred, the incident was discovered at the end of the procedure.No clinical impact to impact.The trocar that has been reported in this cer was used throughout the case as the camera/scope trocar and it was not exchanged or removed till the end of the case.Additional information received from an applied medical representative vi email on 15nov2024: no images available as the sample will be returning.Confirmed with tm regarding what part of the seal came off and tm confirmed it is the shield that fragmented.No sharp instrument was used and no internal seal components was removed or cut in order to inspect the damaged component.Additional information received from an applied medical representative vi email on 18nov2024: tm confirmed it was a piece/pieces that fragmented and not the whole shield.Unfortunately, cannot confirm if it was a single piece or multiple pieces that fragmented.Type of intervention: no replacement device and all fragments were removed from the abdomen.Patient status: no injury or death to patient.
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of shield dislodgment and a torn septum.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.
Event or Problem Description
Procedure performed: laparoscopic anterior resection event description: procedure was coming to an end and the trocar was removed from the abdomen.The surgeons went back into the abdomen through a different trocar to have a final check and wash out, a fragment of the septum fanned instrument guide had appeared to come off the trocar and was inside the patient.All fragments were collected.Unsure of what action or when the incident occurred, the incident was discovered at the end of the procedure.No clinical impact to impact.The trocar that has been reported in this cer was used throughout the case as the camera/scope trocar and it was not exchanged or removed till the end of the case.Additional information received from an applied medical representative vi email on 15nov24: no images available as the sample will be returning.Confirmed with tm regarding what part of the seal came off and tm confirmed it is the shield that fragmented.No sharp instrument was used and no internal seal components was removed or cut in order to inspect the damaged component.Additional information received from an applied medical representative vi email on 18nov24: tm confirmed it was a piece/pieces that fragmented and not the whole shield.Unfortunately, cannot confirm if it was a single piece or multiple pieces that fragmented.Type of intervention: no replacement device, and all fragments were removed from the abdomen.Patient status: no injury or death to patient.

• 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: 21201170
• Report Number: 2027111-2025-00326
• Device Sequence Number: 20906159
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658
• 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): 05/09/2025

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: CFF73
• Device Catalogue Number: 101477591
• Device Lot Number: 1526967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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: CAMERA, SCOPE, TROCAR.
• Patient Sex: Unknown