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	10/04/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: fundoplication.Event description: after incision, the trocar was placed in the abdominal wall with light pressure and turning as recommended.At the end of the surgery by removing the trocars, the surgeon detected that the trocar was broken.The missing part was immediately searched for, but without success.It is still in the abdominal cavity.So far no indicators for injury, no symptoms until today.Additional information was received by an applied medical representative via email on 18oct24: it was confirmed it was cannula that broke off.Additional information was received by an applied medical representative via email on 18oct24: confirmed it was the tip of the cannula that broke.It was not used with a robot.There were no instruments inside of the cannula at the time of incident.Type of intervention: the missing part was immediately searched for, but without success.Patient status: so far no indicators for injury.
Event or Problem Description
Procedure performed: fundoplication.Event description: after incision, the trocar was placed in the abdominal wall with light pressure and turning as recommended.At the end of the surgery by removing the trocars, the surgeon detected that the trocar was broken.The missing part was immediately searched for, but without success.It is still in the abdominal cavity.So far, no indicators for injury, no symptoms until today.Additional information was received by an applied medical representative via email on 18oct24: it was confirmed it was cannula that broke off.Additional information was received by an applied medical representative via email on 18oct24: confirmed it was the tip of the cannula that broke.It was not used with a robot.There were no instruments inside of the cannula at the time of incident.Additional information was received by an applied medical representative via email on 30dec24: the tm had been in contact with the leading nurse before christmas regarding patient status.They indicated the patient did not show up again and they did not receive communication from after the treatment positions i.E.Family doctor.They assumed everything is alright.Patient status updated.Type of intervention: the missing part was immediately searched for, but without success.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation visual inspection confirmed the complainant¿s experience of a cannula tip fracture.Based on the condition of the returned unit, 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] updated section d1.Brand name and d4.Primary unique device identification (udi) number.

• 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: 20496297
• Report Number: 2027111-2024-00879
• Device Sequence Number: 3519927
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 1525304
• 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: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENERGY, STAPLING, GRASPERS, SCISSORS.
• Patient Sex: Unknown