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	08/20/2025
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: laparoscopic cholecystectomy.Event description: information provided by applied medical representative via phone on 21aug2025: while trying to enter the abdomen, the tip of the trocar broke.It looks like they melted it.Additional information provided by applied medical representative on 27aug2025: the only additional information i was able to get was that there was no harm to the patient and the case was completed.Additional information provided by applied medical representative on 02sep2025: the bend/break caused particulation.All the pieces were removed from the patient.The trocar was inserted with rotation.There was difficulty during insertion, there was resistance.This trocar was not used with a robot.Found the lot#: 1553358.Intervention: surgeon did wound exploration and ¿looked with laparoscopic camera throughout entire abdomen and did not see a piece of plastic.¿ kub was completed and read clear by radiology.Wound was closed.Patient status: no patient injury indicated.Patient went home the next day without issues.
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 fractured obturator tip.The clear fragment was identified to be part of the obturator.Based on the condition of the returned unit and description of the event, it is possible that the reported event was caused by heat from the scope and force exerted on the obturator during insertion.However, the exact root cause could not be determined.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: information provided by applied medical representative via phone on 21aug2025: while trying to enter the abdomen, the tip of the trocar broke.It looks like they melted it.Additional information provided by applied medical representative on 27aug2025: the only additional information i was able to get was that there was no harm to the patient and the case was completed.Additional information provided by applied medical representative on 02sep2025: the bend/break caused particulation.All the pieces were removed from the patient.The trocar was inserted with rotation.There was difficulty during insertion, there was resistance.This trocar was not used with a robot.Found the lot#1553358 intervention: surgeon did wound exploration and ¿looked with laparoscopic camera throughout entire abdomen and did not see a piece of plastic.¿ kub was completed and read clear by radiology.Wound was closed.Patient status: no patient injury indicated.Patient went home the next day without issues.

• 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: 23022534
• Report Number: 2027111-2025-00755
• Device Sequence Number: 9546944
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 101245701
• Device Lot Number: 1553358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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
• Patient Sex: Unknown