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	11/20/2024
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: laparoscopic bariatric bypass.Event description: event date: 20nov2024, model#: cff71, lot#: 1525891.The device malfunction occurred when removing the trocar.When removing the trocar at the end of the procedure it was noticed a piece was broken off the tip of the cannula.They (the surgical team) noticed it earlier and were able to locate the piece.No patient injury occurred.The procedure was completed laparoscopically.The broken piece was noticed at the end when pulling out the trocar.Other devices used during procedure: laparoscopic instruments and stapler.The surgical team were able to locate the broken piece before closing so no patient injury.Intervention: completed the case laparoscopically.The broken piece was noticed at the end when pulling out the trocar.Patient status: they were able to locate the broken piece before closing so no patient injury.
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.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 were performed, and no trends were identified.
Event or Problem Description
Procedure performed: laparoscopic bariatric bypass event description: the device malfunction occurred when removing the trocar.When removing the trocar at the end of the procedure it was noticed a piece was broken off the tip of the cannula.They (the surgical team) noticed it earlier and were able to locate the piece.No patient injury occurred.The procedure was completed laparoscopically.The broken piece was noticed at the end when pulling out the trocar.Other devices used during procedure: laparoscopic instruments and stapler.The surgical team were able to locate the broken piece before closing so no patient injury.Intervention: completed the case laparoscopically.The broken piece was noticed at the end when pulling out the trocar.Patient status: they were able to locate the broken piece before closing so no patient injury.

• 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: 20848989
• Report Number: 2027111-2024-00940
• Device Sequence Number: 7942470
• 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: Non-Healthcare Professional
• 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: CFF71
• Device Catalogue Number: 101470694
• Device Lot Number: 1525891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 03/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown