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

Model Number	CFF33
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: lap nissen.Event description: dr was about to start his case which is a lap nissen and wanted to enter the patient via the entry trocar when he was met with resistance upon placing the trocar on the patient.He then inspected the tip and found that it was bent back and was not able to enter with the introducer and was also unable to remove the introducer so a new trocar was opened and the procedure continued.Additional information received from an applied medical representative via email on 04feb25: no images are available as the trocar was immediately double red bagged.Unknown on how the trocar was inserted.Confirmed if was the obturator that bent and unable to be pulled out from the sleeve.Intervention: a second device was opened and the procedure was completed with the second device.Patient status: patient is normal.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant¿s experience of a bent obturator tip.Tip fragmentation was observed which was not reported by the complainant.The clear fragment was identified to be part of the obturator tip.Based on the condition of the returned unit and description of the event, it is likely the obturator tip bent due to insertion force.It is likely that the obturator tip fracture occurred after the reported event during transit to applied medical.Applied medical has performed a historical trend analysis and review of production records, and no trends were identified.This event was initially reported based on the returned unit.However, upon evaluation completion of the returned unit and further examination of the event description, applied medical determined that this event is not reportable as a bent obturator is unlikely to cause or contribute to death or serious injury.
Event or Problem Description
Procedure performed: lap nissen.Event description: dr was about to start his case which is a lap nissen and wanted to enter the patient via the entry trocar.When he was met with resistance upon placing the trocar on the patient.He then inspected the tip and found that it was bent back and was not able to enter with the introducer and was also unable to remove.The introducer so a new trocar was opened and the procedure continued.Additional information received from an applied medical representative via email on 04feb25: no images are available as the trocar was immediately double red bagged.Unknown on how the trocar was inserted.Confirmed if was the obturator that bent and unable to be pulled out from the sleeve.Intervention: a second device was opened and the procedure was completed with the second device.Patient status: patient is normal.

• 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: 21767494
• Report Number: 2027111-2025-00456
• Device Sequence Number: 20948255
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 1530317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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: HYSTROSCOPE.
• Patient Sex: Unknown