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

Model Number	CTF75
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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: sleeve gastrectomy.Event description: optics damaged due to regular friction during passage through.Waiting for further details.Additional information received by an applied medical representative via email on 20nov2025: the surgeon encountered resistance when inserting the optical trocar, which caused it to rub.When the surgical assistant manipulates the trocar, she has to hold it in place, otherwise it slips out of the abdominal cavity.This is not the first time this has happened.The problem is recurring.Additional information received from an applied medical representative on 21nov2025: when the surgeon felt the resistance, did he continue to use that trocar or did he change to a new trocar? continue to use that trocar.Additional information received from an applied medical representative on 25nov2025: every time this trocar is used, the assistant systematically holds the trocar to prevent it from coming out of the abdominal cavity.I don't think they report it to us every time.Additional information received from an applied medical representative on 18dec2025: resistance was felt when the obturator was inserted (not during instrument exchange).Optics means laparoscope.Regarding the type of damage (smudging or actual physical damage): no damage only resistance when was inserted.The resistance was with cannula (not obturator).Additional info received from the ame qc team regarding returned units on 20nov2025 written retrospectively on 19dec2025: additional units returned and with mismatch lot number.Event unit ctf75 amended to lot number: 1540302 and added ctb73 lot: 1563520 what was received.Intervention: continue to use that trocar.Patient status: patient is ok.

• Brand Name: KII FIOS DUAL PACK
• 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: 24028688
• Report Number: 2027111-2026-00316
• Device Sequence Number: 8998194
• Product Code: GCJ
• UDI-Device Identifier: 00607915129903
• UDI-Public: (01)00607915129903
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K041795
• 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): 05/19/2026

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: CTF75
• Device Catalogue Number: 101473279
• Device Lot Number: 1540302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2025
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Patient Sex: Unknown