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

Model Number	CFF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: bariatric procedure.Event description: [hospital name] had a case on (b)(6) 2024 with dr.[name] doing a bariatric procedure and at the end of the case when they removed the trocar they noticed it was cracked at the tip and a small piece of plastic was missing.They do not know when it happened.They looked for it inside the patient and on the sterile or tables but never found it.The patient was notified by the surgeon.No issues have occurred with the patient at this point.The hospital did file an incident report.The trocar was cff71.Lot# 1497050.The color of the piece was clear.A piece of the tip of the trocar fell out.No instrumentation was being used at the time of the incident.They were removing the trocar at the end of the procedure.Laparoscopic instruments were used prior to the incident no internal seal components were removed or cut in order to inspect the damaged component.Patient status: no issues have occurred with the patient at this point.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a fractured cannula tip.Based on the event description and similar events, it is likely that the cannula tip fractured was due to instrumentation coming into contact with the tip and/or excess force was exerted on the tip during the procedure.It is also possible that the cannula tip material was more susceptible to fracture.A historical trend analysis and review of production records was performed and no relevant documentation was identified.Correction: the brand name in section d1 and the primary/additional di numbers in section d4 have been updated.
Event or Problem Description
Procedure performed: bariatric procedure.Event description: [hospital name] had a case on (b)(6) 2024 with dr.[name] doing a bariatric procedure and at the end of the case when they removed the trocar, they noticed it was cracked at the tip and a small piece of plastic was missing.They do not know when it happened.They looked for it inside the patient and on the sterile or tables but never found it.The patient was notified by the surgeon.No issues have occurred with the patient at this point.The hospital did file an incident report.The trocar was cff71.Lot# 1497050.The color of the piece was clear.Additional information provided by applied medical account manager on 19jun2024 via email: a piece of the tip of the trocar fell out.No instrumentation was being used at the time of the incident.They were removing the trocar at the end of the procedure.Laparoscopic instruments were used prior to the incident no internal seal components were removed or cut in order to inspect the damaged component.Patient status: no issues have occurred with the patient at this point.

• 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19580145
• Report Number: 2027111-2024-00702
• Device Sequence Number: 7392608
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 06/27/2026
• Device Model Number: CFF71
• Device Catalogue Number: 101470694
• Device Lot Number: 1497050
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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