MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF03
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic tubal ligation.Event description: complaint created based off medwatch#: mw5117742.Kii fios/z-thread leaked air due to a faulty valve.Pt (patient) undergoing laparoscopic tubal ligation.No harm to the patient.Product returned to manufacturer 17may2023.Additional information received on 02jun2023 via email from the user facility: the physician resolved the issue by removing the trocar and replacing with another trocar.Laparoscopic instruments were being used at the time of the incident.No other instrumentation was used prior to the incident.There was no component damage.Unknown if the obturator was inside the seal when the product was returned.Additional information received on 05jun2023 via email from applied medical account manager: event date is confirmed to be (b)(6) 2023.Complaint device was returned a few days later by customer.Type of intervention: the physician resolved the issue by removing the trocar and replacing with another trocar.Patient status: no harm to the patient.
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: laparoscopic tubal ligation.Event description: complaint created based off medwatch mw5117742.Kii fios/z-thread leaked air due to a faulty valve.Pt (patient) undergoing laparoscopic tubal ligation.No harm to the patient.Product returned to manufacturer 17may2023.Additional information received on 02jun2023 via email from the user facility: the physician resolved the issue by removing the trocar and replacing with another trocar.Laparoscopic instruments were being used at the time of the incident.No other instrumentation was used prior to the incident.There was no component damage.Unknown if the obturator was inside the seal when the product was returned.Additional information received on 05jun2023 via email from applied medical account manager: event date is confirmed to be (b)(6) 2023.Complaint device was returned a few days later by customer.Type of intervention: the physician resolved the issue by removing the trocar and replacing with another trocar.Patient status: no harm to the patient.
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 reviewed the details surrounding the event and is unable to determine the exact root cause of the event.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # mw5117742.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 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: 17066664
• Report Number: 2027111-2023-00477
• Device Sequence Number: 17668482
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)251215(30)01(10)1476932
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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: 12/15/2025
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1476932
• Was Device Available for Evaluation?: No
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAPAROSCOPIC INSTRUMENTS.
• Patient Age: 29 YR
• Patient Sex: Female