MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII FIOS ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being 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: the trocar disassembled during surgery, releasing the green plastic half ring inside the abdominal cavity.The material that fell into the abdominal cavity was completely removed by the surgeon.The procedure was completed normally, with no complications for the patient.The hospital discarded the product.The procedure was completed without any complications for the patient.Product is not available for return.Patient status: the procedure was completed without any complications for the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a green/teal half ring.Visual inspection confirmed the complainant¿s experience of particulate.However, additional testing confirmed that the material of the returned particulate was unlikely to have originated from applied medical¿s product.The visual inspection of the event unit and the testing performed on the returned particulate confirmed that an applied medical product was not involved in the reported event.Therefore, a product malfunction did not occur with an applied medical product and the event is not reportable.
Event or Problem Description
Procedure performed: unknown.Event description: the trocar disassembled during surgery, releasing the green plastic half ring inside the abdominal cavity.The material that fell into the abdominal cavity was completely removed by the surgeon.The procedure was completed normally, with no complications for the patient.The hospital discarded the product.The procedure was completed without any complications for the patient.Product is not available for return.Additional information was received on 21mar2023 via email from the distributor: the hospital found the product and forwarded it to us.Expect product return for investigation.Patient status: the procedure was completed without any complications for the patient.

• Brand Name: CTF33, 11X100 KII FIOS ZTHR 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: 16492489
• Report Number: 2027111-2023-00367
• Device Sequence Number: 15044609
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)250424(30)01(10)1447322
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 04/24/2025
• Device Model Number: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1447322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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