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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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: unknown.Event description: a fault has occurred with item sku 153343, ref: ctf03, lot: 1411612, supplied from the ndc.On (b)(6) 2021 during the thoracic part of the procedure it was noticed that the tip of 5mm trocar was missing.Presumed in patient but not found due to small size and plastic , not show on xray.Expiry date of product march 2024.Patient status: no patient injury has been 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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: unknown.Event description: complaint 1 of 5: (b)(4) [mfr report # 2027111 - 2022 - 00557]; complaint 2 of 5: (b)(4) [mfr report # 2027111 - 2022 - 00558]; complaint 3 of 5: (b)(4) [mfr report # 2027111 - 2022 - 00596]; complaint 4 of 5: (b)(4) [mfr report # 2027111 - 2022 - 00597]; complaint 5 of 5: (b)(4) [mfr report # 2027111 - 2022 - 00598].A fault has occurred with item sku 153343, ref: (b)(4), lot: 1411612, supplied from the ndc.On (b)(6) 2021 during the thoracic part of the procedure it was noticed that the tip of 5mm trocar was missing.Presumed in patient but not found due to small size and plastic , not show on xray.Expiry date of product march 2024.No of instances: 2-5.Additional information received by email from applied medical representative on 21apr22: i have tried to follow up with this and no one will respond to me.Patient status: no patient injury has been reported.

• 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: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14112944
• Report Number: 2027111-2022-00558
• Device Sequence Number: 2135143
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)240324(30)01(10)1411612
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 03/24/2024
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1411612
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose