MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0Q19, KII 8X100 Z-THR OPT SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	C0Q19
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
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: gastrectomy.Event description: the device was used for gastrectomy when the event occurred."during surgery using an artisential device after trocar insertion to a patient, the artisential device was temporarily attempted to be removed from the trocar, but it was not removed." there were no changes in patient health resulting from the event."the surgery was replaced with a new product" in order to resolve the event.Product is available for return.Additional information received via email 02nov2021 from applied medical representative: the damage to the trocar tip was caused by pulling the artisential device from the trocar with force.The artisential device was the only instrumentation used prior to the incident.Intervention: the surgery was replaced with a new product.Patient status: there was no problem with the patient.
Event or Problem Description
Procedure performed: gastrectomy.Event description: the device was used for gastrectomy when the event occurred."during surgery using an artisential device after trocar insertion to a patient, the artisential device was temporarily attempted to be removed from the trocar, but it was not removed." there were no changes in patient health resulting from the event."the surgery was replaced with a new product" in order to resolve the event.Product is available for return.Additional information received via email 02nov2021 from applied medical representative: the damage to the trocar tip was caused by pulling the artisential device from the trocar with force.The artisential device was the only instrumentation used prior to the incident.Intervention: the surgery was replaced with a new product.Patient status: there was no problem with the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.Based on the condition of the returned unit, it is likely that the cannula tip fractured due to instrumentation coming in contact with the cannula tip during the procedure.It is also possible that the cannula was more susceptible to breakage.

• Brand Name: C0Q19, KII 8X100 Z-THR OPT SYS 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 12796824
• Report Number: 2027111-2021-00714
• Device Sequence Number: 17448672
• Product Code: GCJ
• UDI-Device Identifier: 00607915115920
• UDI-Public: (01)00607915115920(17)231208(30)01(10)1402966
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K060096
• 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): 01/04/2022

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: 12/08/2023
• Device Model Number: C0Q19
• Device Catalogue Number: 101063001
• Device Lot Number: 1402966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: THE ARTISENTIAL DEVICE WAS USED.
• Patient Sex: Unknown