MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: unknown.Event description: i tried to cancel (b)(4) boxes of item ctf01 due to a reported issue with the product.We will need to return these boxes once they arrive at our facility.I have attached the invoice showing the (b)(4) boxes in transit.Kindly inform customer service about the return i will be requesting for this product.Additional information provided by applied medical representative on 18sep2024 via email: i spoke to the customer this morning and it seems they would like to return all five boxes of item #ctf01 due to an issue they had with this item during surgery.The customer stated that the trocar broke inside the patient during a procedure.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit is not returning to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Additional Manufacturer Narrative
This medwatch report # 2027111-2024-00851 was generated from a user facility notification.Following applied medical¿s submission of the initial report regarding medwatch report # 2027111-2024-00851, applied medical determined that this medwatch report is for the same event that was captured in medwatch report # 2027111-2023-00533.Therefore, medwatch report # 2027111-2024-00851 is a duplicate of medwatch report # 2027111-2023-00533.The result of the complainant¿s experience investigation is documented under medwatch report # 2027111-2023-00533.
Event or Problem Description
Procedure performed: unknown.Event description: i tried to cancel 5 boxes of item ctf01 due to a reported issue with the product.We will need to return these boxes once they arrive at our facility.I have attached the invoice showing the 5 boxes in transit.Kindly inform customer service about the return i will be requesting for this product.Additional information provided by applied medical representative on 18sep2024 via email: i spoke to the customer this morning and it seems they would like to return all five boxes of item #ctf01 due to an issue they had with this item during surgery.The customer stated that the trocar broke inside the patient during a procedure.Patient status: no patient injury or illness was reported.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• 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: 20340404
• Report Number: 2027111-2024-00851
• Device Sequence Number: 15440072
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: CTF01
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 05/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown