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

Model Number	CTF75
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: sleeve gastrectomy.Event description: [translation] introduction of the trocar per op, when the camera is inserted, the trocar valve falls into the patient's belly, thus detaching itself from the stem.Additional information received from an applied medical representative via email on 09jul25: there was no patient injury and the patient is fine, event date 30jun25 with procedure performed was sleeve gastrectomy and concomitant devices used during are trocar 5mm and grasper.All black in colour pieces were retrieved from the patient and it was confirmed the entire component fell out.Before and t the time of the incident a fenestrated clamp.The internal seal components was removed or cut in order to inspect the damaged component.No images/video available.Device is available for return.Intervention: valve retrieved from the belly - change of trocar.Patient status: there was no patient injury and the patient is fine.
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.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a black fragment.Visual inspection confirmed the complainant¿s experience of seal fragmentation.The black fragment matched the missing portion of the septum, an internal rubber component of the seal.Based on the description of the event and condition of the returned unit, the septum fragmentation was most likely caused by an asymmetrical instrument that was inserted or removed through the trocar in non-axial manner.Applied medical¿s instructions for use (ifu) states that, ¿extra care should be used when inserting angular and asymmetrical instruments, such as ¿j¿ hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.¿ applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as septum fragmentation is unlikely to lead to death or serious deterioration in state of health.
Event or Problem Description
Procedure performed: sleeve gastrectomy.Event description: [translation] introduction of the trocar per op, when the camera is inserted, the trocar valve falls into the patient's belly, thus detaching itself from the stem.Additional information received from an applied medical representative via email on 09jul25: there was no patient injury and the patient is fine, event date 30jun25 with procedure performed was sleeve gastrectomy and concomitant devices used during are trocar 5mm and grasper.All black in colour pieces were retrieved from the patient and it was confirmed the entire component fell out.Before and t the time of the incident a fenestrated clamp.The internal seal components was removed or cut in order to inspect the damaged component.No images/video available.Device is available for return.Intervention: valve retrieved from the belly - change of trocar.Patient status: there was no patient injury and the patient is fine.

• 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: 22494640
• Report Number: 2027111-2025-00645
• Device Sequence Number: 14496822
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 1528884
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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: TROCAR 5MM, FENESTRATED CLAMP GRASPER
• Patient Sex: Unknown