MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF01, 5X150 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Event description: per the rep, the tip of the trocar broke off into the patient.Per the pictures provided it appeared that the tip was able to be retrieved from the patient.Patient seems to be fine.Patient status: "patient seems to be fine.".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit and a clear fragment were provided, confirming the complainant¿s experience of a fractured cannula tip.The clear fragment was identified to be part of the cannula tip.Based on the description of the event and the photographs of the event unit, it is possible that the fractured cannula tip was caused by an object or instrument coming in contact with the cannula tip and/or excess stress was exerted on the cannula tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.
Event or Problem Description
Procedure performed: laproscopic peritoneal window.Event description: per the rep, the tip of the trocar broke off into the patient.Per the pictures provided it appeared that the tip was able to be retrieved from the patient.Patient seems to be fine.Additional information was received via email on 26jun2023 from applied medical representative: procedure was a laproscopic peritoneal window.There was no patient injury.The break was noticed at the end of the case so another trocar was not needed to complete the case.There was no difficulty inserting the trocar.The break did not cause particulation.All pieces were retrieved from the patient.The trocar was not used with a robot.The product is now available for return.Intervention: case was completed with complaint device.Patient status: no patient injury.Patient is ok.
Event or Problem Description
Procedure performed: laproscopic peritoneal window.Event description: per the rep, the tip of the trocar broke off into the patient.Per the pictures provided it appeared that the tip was able to be retrieved from the patient.Patient seems to be fine.Additional information was received via email on 26jun2023 from applied medical representative: procedure was a laproscopic peritoneal window.There was no patient injury.The break was noticed at the end of the case so another trocar was not needed to complete the case.There was no difficulty inserting the trocar.The break did not cause particulation.All pieces were retrieved from the patient.The trocar was not used with a robot.The product is now available for return.Intervention: case was completed with complaint device.Patient status: no patient injury.Patient is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a cannula tip fracture.The clear fragment was identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely that the fractured cannula tip was caused by an object or instrument coming into contact with the cannula tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.

• Brand Name: CFF01, 5X150 KII FIOS ADVFIX 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17073310
• Report Number: 2027111-2023-00478
• Device Sequence Number: 6756686
• Product Code: GCJ
• UDI-Device Identifier: 00607915123147
• UDI-Public: (01)00607915123147(17)251018(30)01(10)1464165
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2023

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 Expiration Date: 10/18/2025
• Device Model Number: CFF01
• Device Catalogue Number: 101453601
• Device Lot Number: 1464165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 05/31/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/10/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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