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	09/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Procedure performed: robotic procedure (laparoscopic nephrectomy).Event description: [translation] during the robotic procedure (laparoscopic nephrectomy), a piece of trocar was discovered when closing the incision in the left iliac fossa.After inspecting the trocar during its removal, the surgeon realized that the distal tip was broken in several places.Three pieces were extracted from the patient.Current patient status: procedure extended to check for other fragments in the patient's abdomen.Actions taken by the healthcare facility to treat the patient: patient notified.A ct scan was performed to check again for trocar fragments.Immediate withdrawal of the batches in question.Intervention: procedure extended to check for other fragments in the patient's abdomen.A ct scan was performed to check again for trocar fragments.Patient status: patient is good.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation along with two (2) sterile units.Visual inspection confirmed the complaint¿s experience of a cannula tip fracture.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.
Event or Problem Description
Procedure performed: robotic procedure (laparoscopic nephrectomy).Event description: [translation] during the robotic procedure (laparoscopic nephrectomy), a piece of trocar was discovered when closing the incision in the left iliac fossa.After inspecting the trocar during its removal, the surgeon realized that the distal tip was broken in several places.Three pieces were extracted from the patient.Procedure extended to check for other fragments in the patient's abdomen.Actions taken by the healthcare facility to treat the patient: patient notified.A ct scan was performed to check again for trocar fragments.Immediate withdrawal of the batches in question.Intervention: procedure extended to check for other fragments in the patient's abdomen.A ct scan was performed to check again for trocar fragments.Patient status: patient is good.

• 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: 23442546
• Report Number: 2027111-2025-00842
• Device Sequence Number: 20068853
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 1560801
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROBOT
• Patient Sex: Unknown