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

Model Number	CTF12
Medical Device Problem Codes	Material Fragmentation (1261); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: unknown event description: [translation] "the operating room reported an incident involving a threaded trocar.Defect: foreign body (rubber?) present in the trocar.The patient was given antibiotic prophylaxis to prevent the risk of infection.Another trocar was used to complete the procedure.The trocar was kept for expert examination.Can you tell me if you've received any other reports on this reference/batch, or if the analysis of the production batch mentions any deviations?" closing letter requested.Additional information received from sales manager via email on 31jul2024: [translation]: "by the way, the patient is doing very well (if anyone is interested) and has had no secondary infections."- doctor intervention: another trocar was used to complete the procedure.Patient status: a preventive antibiotic treatment was made by the surgeon, patient is doing well.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: [translation]: "the operating room reported an incident involving a threaded trocar.Defect: foreign body (rubber?) present in the trocar.The patient was given antibiotic prophylaxis to prevent the risk of infection.Another trocar was used to complete the procedure.The trocar was kept for expert examination.Can you tell me if you've received any other reports on this reference/batch, or if the analysis of the production batch mentions any deviations?" closing letter requested.Additional information received from sales manager via email on 31jul2024: [translation]: "by the way, the patient is doing very well (if anyone is interested) and has had no secondary infections."- doctor.Intervention: another trocar was used to complete the procedure.Patient status: a preventive antibiotic treatment was made by the surgeon, patient is doing well.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the presence of a black particulate inside the obturator.Testing was performed on the particulate; however, the source and material composition could not be determined.Based on the testing performed, it is possible that the particulate originated from the manufacturing process and came loose as the product was being used.It is also possible that the particulate originated from the customer.However, the exact time and root cause of the particulate is unknown.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• Brand Name: KII FIOS DUAL PACK
• 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: 20047042
• Report Number: 2027111-2024-00792
• Device Sequence Number: 18116886
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CTF12
• Device Catalogue Number: 101472858
• Device Lot Number: 1519086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown