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: in may 2024, two different surgeons dr.[name] and dr.[name], encountered issues with a specific trocar (cfr01) during separate laparoscopic cholecystectomy (lab chole) procedures.Both surgeons reported that the trocar broke during the surgical cases.As a result of these incidents, the surgeons stopped using the cfr01 trocar catalog and have 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 issues with the design or manufacturing of this particular device.Type of intervention: they replaced the device with another trocar from different manufacturer.Patient status: patient is fine.
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 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: complaint (b)(4), complaint 1 of 2.(mdr report id: 2027111-2024-00782) complaint (b)(4), complaint 2 of 2.(mdr report id: 2027111-2024-00819) in (b)(6) 2024, two different surgeons dr.[name] and dr.[name], encountered issues with a specific trocar (cfr01) during separate laparoscopic cholecystectomy (lab chole) procedures.Both surgeons reported that the trocar broke during the surgical cases.As a result of these incidents, the surgeons stopped using the cfr01 trocar catalog and have 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 issues with the design or manufacturing of this particular device.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 field team on september 12, 2024 through email: the hospital does not have any documentation indicating that it was discarded.Type of intervention: they replaced the device with another trocar from different manufacturer.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: 19955908
• Report Number: 2027111-2024-00782
• Device Sequence Number: 8810468
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 08/09/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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