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

Model Number	CTF33
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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: "on (b)(6) 2024@ 1140 hrs, patient, female, had emergency laparoscopic cholecystectomy in ot 5 at 1215hrs", "while surgery on going applied medical kii fios blade less trocar 10 mm sleeve broken in to two pieces, patient was stable, no incident of any anaphylactic reaction, immediately complete trocar removed, cleaned the wound with betadine, and replaced with another brand trocar.Surgery finished at 1425hrs, detail of the consumable: kii fios, first entry, ref: ctf 33, expiry: 11/07/2027." intervention: immediately complete trocar removed, cleaned the wound with betadine, and replaced with another brand trocar patient status: patient was stable, no incident of any anaphylactic reaction.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: "on (b)(6) 2024 @ 1140 hrs ,patient, female, had emergency laparoscopic cholecystectomy in ot 5 at 1215hrs", "while surgery on going applied medical kii fios blade less trocar 10 mm sleeve broken in to two pieces, patient was stable, no incident of any anaphylactic reaction, immediately complete trocar removed, cleaned the wound with betadine, and replaced with another brand trocar.Surgery finished at 1425hrs, detail of the consumable: kii fios, first entry, ref ctf 33, expiry :11/07/2027." intervention: immediately complete trocar removed, cleaned the wound with betadine, and replaced with another brand trocar.Patient status: patient was stable, no incident of any anaphylactic reaction.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainants experience of a fractured cannula shaft.The cannula wall thickness near the fracture location was measured and did not meet specifications.Based on the condition of the returned unit, it is possible that the reported event may have occurred during device manipulation within the incision site or during insertion.It is possible the cannula shaft fracture was due to uneven cannula wall thickness which can cause the cannula to be more susceptible to fracture.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.

• 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: 20821141
• Report Number: 2027111-2024-00935
• Device Sequence Number: 15664386
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: CTF33
• Device Catalogue Number: 101219301
• Device Lot Number: 1528882
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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 Age: 44 YR
• Patient Sex: Female