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

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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: unk.Event description: applied medical representative provided additional information for complaints (b)(4) (report id: 2027111-2024-00939) and (b)(4) (report id: 2027111-2024-00940), and reported that the same hospital, along with the same surgeon experienced a similar malfunction to the two complaints mentions.Complaints (b)(4) (report id: 2027111-2024-00939) and (b)(4) (report id: 2027111-2024-00940) malfunctions are cannula tip fractures.It happened today ((b)(6) 2024) at the same hospital with the same doctor.They threw out the packaging and the trocar but they did take this picture.The trocar is cracked but the piece didn¿t completely fall off.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: unk.Event description: applied medical representative provided additional information for complaints: (b)(4) (report id: 2027111-2024-00939) and (b)(4) (report id: 2027111-2024-00940), and reported that the same hospital, along with the same surgeon experienced a similar malfunction to the two complaints mentions.Complaints: (b)(4) (report id: 2027111-2024-00939) and (b)(4) (report id: 2027111-2024-00940) malfunctions are cannula tip fractures.It happened today on (b)(6) 2024) at the same hospital with the same doctor.They threw out the packaging and the trocar but they did take this picture.The trocar is cracked but the piece didn't completely fall off.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformance's that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records was performed, and no trends were 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: 20904301
• Report Number: 2027111-2024-00950
• Device Sequence Number: 15736476
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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: CFF71
• Device Catalogue Number: 101470694
• Device Lot Number: 1525891
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown