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	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation but lot number is provided.A follow-up report will be provided upon completion of the investigation.This report is a follow-up to medwatch (b)(4).
Event or Problem Description
Name of procedure being performed: na (before use).Detailed description of event: complaint created based on medwatch received by email from fda under uf/importer report (b)(4)."a hair was found inside the sealed sterile package." product not available for return.Additional information was received from [name] via email on 29jan2024: "this complaint occurred at [facility] not [facility]." the event occurred before use.The product is not available for return as the "event occurred over 90 days ago".Type of intervention: na (before use).Patient status: na (before use).
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided.Visual inspection confirmed the presence of hair inside the sterile unopened pouch.Based on photograph of the event unit, it is most likely that the hair originated from an operator during the manufacturing process.This report is a follow-up to medwatch # (b)(4).
Event or Problem Description
Detailed description of event: complaint created based on medwatch received by email from fda under uf/importer report (b)(4)."a hair was found inside the sealed sterile package." product not available for return.Additional information was received from [name] via email on 29jan2024: "this complaint occurred at [facility] not [facility]." the event occurred before use.The product is not available for return as the "event occurred over 90 days ago".

• 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: 18627613
• Report Number: 2027111-2024-00369
• Device Sequence Number: 15426085
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)251106(30)01(10)1467548
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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 Expiration Date: 11/06/2025
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1467548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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