MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII FIOS FIRST ENTRY; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown event description: complaint (b)(4), complaint 1 of 3.(mfr report # 2027111-2024-00815) complaint (b)(4), complaint 2 of 3.(mfr report # 2027111-2024-00816) complaint (b)(4), complaint 3 of 3.When lodging complaint (b)(4), it was customer remarks were noticed on the pcf that there have been multiple ctf33 and c0r47 ports with the same issue in recent weeks.When the amnz territory manager was approached to obtain further information on the additional incidents, she reached out to the customer and obtained the following information that was provided via email on 27-aug-2024."i have spoken to the account, and they know of 3 total incidents.So far: 2 x ctf33 and 1 x c0r47.In all cases, they continued using the trocar despite the resistance." the following are the complaints raised so far.1 x ctf33 - complaint (b)(4) 1 x c0r47 - complaint (b)(4).1 x ctf33 - complaint (b)(4).Patient status: no patient injury or illness was reported.
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.Applied medical has performed a historical trend analysis and review of production records and no trends were identified.[correction] section d1 has been updated.
Event or Problem Description
The event date is unknown.Procedure performed: unknown.Event description: complaint (b)(4), complaint 1 of 3.(mfr report # 2027111-2024-00815).Complaint (b)(4), complaint 2 of 3.(mfr report # 2027111-2024-00816).Complaint (b)(4), complaint 3 of 3.(mfr report # 2027111-2024-00826).When lodging complaint (b)(4), it was customer remarks were noticed on the pcf that there have been multiple ctf33 and c0r47 ports with the same issue in recent weeks.When the amnz territory manager was approached to obtain further information on the additional incidents, she reached out to the customer and obtained the following information that was provided via email on 27-aug-2024."i have spoken to the account, and they know of 3 total incidents.So far: 2 x ctf33 and 1 x c0r47.In all cases, they continued using the trocar despite the resistance." the following are the complaints raised so far.1 x ctf33 - (b)(4).1 x c0r47 -(b)(4).1 x ctf33 - (b)(4).Patient status: no patient injury or illness was reported.

• Brand Name: KII FIOS FIRST ENTRY
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20185997
• Report Number: 2027111-2024-00826
• Device Sequence Number: 15505836
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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 Model Number: CTF33
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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