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

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
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: endoscopic cardio-thoracic procedure.Event description: while doing the surgery, the registrar noticed a small broken piece of the 11 mm port inside the chest and the surgeon removed the piece.Towards the end of the procedure, they found another broken piece which they have also removed.Surgeon checked inside the chest for any left-over pieces.When the broken 11mm port was out, i checked the broken pieces with the port and surgeon did as well.Surgeon confirmed that he is happy with the collected broken pieces.Additional information received from an applied medical representative via email on 08nov24: procedure to be confirmed early next week.The trocar was inserted in a 10 to 2 twisting motion and no difficulty during insertion.The patient was not considered bariatric with no previous surgeries around the same placement.At the time they noticed the broken fragments of plastic, no instruments was in the cannula.The trocar was not used with a robot.Type of intervention: it was used throughout the procedure and no resolution was taken to replace the device during the procedure.Patient status: no injury/death to patient.
Event or Problem Description
Procedure performed: video-assisted thoracic surgery.Event description: while doing the surgery, the registrar noticed a small broken piece of the 11 mm port inside the chest and the surgeon removed the piece.Towards the end of the procedure, they found another broken piece which they have also removed.Surgeon checked inside the chest for any left-over pieces.When the broken 11mm port was out, i checked the broken pieces with the port and surgeon did as well.Surgeon confirmed that he is happy with the collected broken pieces.Additional information received from an applied medical representative via email on 08nov24: procedure to be confirmed early next week.The trocar was inserted in a 10 to 2 twisting motion and no difficulty during insertion.The patient was not considered bariatric with no previous surgeries around the same placement.At the time they noticed the broken fragments of plastic, no instruments was in the cannula.The trocar was not used with a robot.Additional information received from an applied medical representative via email on 04dec24: confirmed procedure as video-assisted thoracic surgery otherwise known as vats additional information received from an applied medical representative via email on 04dec24: concomitant device as stated by tm ' just a scope was used through that port'.Type of intervention: it was used throughout the procedure and no resolution was taken to replace the device during the procedure.Patient status: no injury/death to patient.
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] section b5 procedure performed updated to video-assisted thoracic surgery based on additional information provided.

• 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: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 20751217
• Report Number: 2027111-2024-00920
• Device Sequence Number: 4399706
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083638
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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 Model Number: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1522000
• Was Device Available for Evaluation?: No
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE
• Patient Sex: Unknown