MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF73, 12X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF73
Medical Device Problem Codes	Break (1069); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: gastrectomy.Event description: report from the applied medical representative: after abdominal insertion, co2 was injected.There was air leak from the cannula.The device was replaced with the new device.There was no instrument used at the time of the incident.Product is available for return.Additional information received via email on 02jan2023 from the applied medical representative: it is difficult to verify exactly where the break occurred.The trocar was inserted without rotation.There was no difficulty during insertion.The break was considered to be a clean break, but it is difficult to verify the details because the dealer has the event unit now.The break didn't cause particulation.The trocar was not used with a robot.The image of the broken cannula is not available.Type of intervention: the case was completed with the new device.Patient status: there was no problem with the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of cannula breakage could not be confirmed as the cannula met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as the cannula breakage could not be confirmed and the air leakage is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: gastrectomy event description: report from the applied medical representative: after abdominal insertion, co2 was injected.There was air leak from the cannula.The device was replaced with the new device.There was no instrument used at the time of the incident.Product is available for return.Additional information received via email on 02jan2023 from the applied medical representative: it is difficult to verify exactly where the break occurred.The trocar was inserted without rotation.There was no difficulty during insertion.The break was considered to be a clean break, but it is difficult to verify the details because the dealer has the event unit now.The break didn't cause particulation.The trocar was not used with a robot.The image of the broken cannula is not available.Type of intervention: the case was completed with the new device.Patient status: there was no problem with the patient.

• Brand Name: CFF73, 12X100 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: 16105948
• Report Number: 2027111-2023-00304
• Device Sequence Number: 18051430
• Product Code: GCJ
• UDI-Device Identifier: 00607915117658
• UDI-Public: (01)00607915117658(17)250403(30)01(10)1445213
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2023

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: 04/03/2025
• Device Model Number: CFF73
• Device Catalogue Number: 101245501
• Device Lot Number: 1445213
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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