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

Model Number	CTF12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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 nissen fundoplication.Event description: when the surgeon put grasper in trocar ctf12 the transparent part of the kii trocar seal fallen in the abdominal.Action being performed when the event occured: grasper [brand name product], 5mm with [brand name product].Additional information received from applied medical representative via email 6nov2025: all pieces retrieved from patient.Component appear to be torn off.No removal or cut of the components in order to inspect the damaged component.During event just grasper and [brand name product] were used.Intervention: use another trocar, [brand name product], patient status: ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component.Visual inspection confirmed the complaint¿s experience of seal component dislodgment.Based on the description of the event and the condition of the returned unit, it is likely the reported event was caused by an asymmetrical instrument that was inserted through the trocar in a 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.
Event or Problem Description
Procedure performed: laparoscopic nissen fundoplication.Event description: when the surgeon put grasper in trocar ctf12 the transparent part of the kii trocar seal fallen in the abdominal.Action being performed when the event occured: grasper [brand name product] 5mm with [brand name product].Additional information received from applied medical representative via email 6nov2025: all pieces retrieved from patient.Component appear to be torn off.No removal or cut of the components in order to inspect the damaged component.During event just grasper and [brand name product] were used.Intervention: use another trocar [brand name product].Patient status: 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: 23572259
• Report Number: 2027111-2025-00863
• Device Sequence Number: 18680786
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707
• 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): 03/16/2026

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: CTF12
• Device Catalogue Number: 101478398
• Device Lot Number: 1564443
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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