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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: lap chole.Event description: information received by an applied medical representative, via email, on (b)(6) 26: as this happened 2 months ago and neither hcp the applied medical rep spoke to were present during the procedure, there isn¿t an overly detailed description of what happened.The best we can ascertain is, the surgeon inserted the scope into the obturator, the tip of the obturator gave way.The tip ended up in the patient and was retrieved immediately by the surgeon; the patient was not affected.The hospital has taken their stock of cff33 out of circulation and await instruction on how to proceed.The affected device is to be collected from theatre, contact email and address below.Additional information received by an applied medical representative, via email, on (b)(6) 26: procedure was lap chole, high bmi patient.Besides the scope, no other instruments were used at the time of the incident.It was not a robotic surgery.One cannula was inserted using the obturator prior to the incident.Pieces fell into the patient and all were retrieved.The trocar was inserted with rotation.Patient was high bmi, staff don¿t recall anything out of the ordinary regarding difficulty during insertion.Intervention: tip retrieved immediately by the surgeon and the hospital has taken their stock of cff33 out of circulation and await instruction on how to proceed.Patient status: the patient was not affected.
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.

• 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: 24520697
• Report Number: 2027111-2026-00417
• Device Sequence Number: 9655745
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: 1570872
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 10/14/2025
• 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