MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR01, 5X150 KII OPT ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFR01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
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: laparoscopic cholecystectomy event description: complaint (b)(4), complaint 1 of 2.(mfr report number 2027111-2024-00782) complaint (b)(4), complaint 2 of 2.In (b)(6) 2024, two different, dr.[name] encountered issues with a specific trocar (cfr01) during laparoscopic cholecystectomy (lab chole) procedures, surgeon reported that the trocar broke during the surgical cases.A result of these incidents, the surgeon stopped using the cfr01 trocar catalog and have a substantial remaining inventory of this product.They would like to understand why the trocar broke during the procedures so they can determine if there are any issues with the design or manufacturing of this particular device.There is no impact clinical impact on the patient additional information received from the field team on september 4, 2024 through email: yes, there were two incidents involving cfr01 with two different surgeons.However, i was instructed to return to the head of the department, which is why i submitted only one pcf form.Intervention: they replaced the device with other trocar from different manufacture.Patient status: patient is fine.
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-conformances 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 performed a historical trend analysis and review of production records and no trends were identified.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: (b)(4), complaint 1 of 2.(mdr report id: 2027111-2024-00782).(b)(4), complaint 2 of 2.(mdr report id: 2027111-2024-00819).In (b)(6) 2024, two different, dr.[name] encountered issues with a specific trocar (cfr01) during laparoscopic cholecystectomy (lab chole) procedures.Surgeon reported that the trocar broke during the surgical cases.A result of these incidents, the surgeon stopped using the cfr01 trocar catalog and have a substantial remaining inventory of this product.They would like to understand why the trocar broke during the procedures so they can determine if there are any issues with the design or manufacturing of this particular device.There is no impact clinical impact on the patient.Additional information received from the field team on september 4, 2024 through email: yes, there were two incidents involving cfr01 with two different surgeons.Additional information received from the field team on september 23: the surgeon experienced the same type of trocar breakage.Type of intervention: they replaced the device with other trocar from different manufacture.Patient status: patient is fine.

• Brand Name: CFR01, 5X150 KII OPT 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: 20138232
• Report Number: 2027111-2024-00819
• Device Sequence Number: 7482316
• Product Code: GCJ
• UDI-Device Identifier: 00607915122294
• UDI-Public: (01)00607915122294(17)250601(30)01(10)1454796
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 06/01/2025
• Device Model Number: CFR01
• Device Catalogue Number: 101453701
• Device Lot Number: 1454796
• 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: 07/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown