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

Model Number	CFF33
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)
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: ni.Event description: [translation] i am writing to report an adverse event that occurred with a trocart kii f i o s fixation ballonnet insufflation 11mm*100mm, reference cff33, lot number 1544901 : trocar valve mismatched and falls into patient's abdomen on insertion.Broken trocar distal tip in patient.Problem visualized on trocar extraction.For your information, the device is available.Patient status: no patient injury or illness was reported.The date of the event is unknown.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear component and two clear fragments.Visual inspection confirmed the complainant's experience of seal component dislodgment and tip fragmentation.The clear component was identified to be the shield, an internal plastic component of the seal.The clear fragments were identified to be part of the cannula tip.Based on the condition of the returned unit, it is likely the shield dislodgement 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." it is likely the cannula tip fragmentation was due to contact with an object or instrument and/or excess stress applied to the tip during the procedure.However, the exact root cause for the fragmentation is unknown.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: ni.Event description: [translation].I am writing to report an adverse event that occurred with a trocart kii f i o s fixation.Ballonnet insufflation 11mm*100mm, reference cff33, lot number 1544901: trocar valve mismatched and falls into patient's abdomen on insertion.Broken trocar distal tip in patient.Problem visualized on trocar extraction.For your information, the device is available.Patient status: no patient injury or illness was reported.The date of the event is unknown.

• 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: 21877986
• Report Number: 2027111-2025-00482
• Device Sequence Number: 8768660
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1544901
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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