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

Model Number	CTF03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Date of event is unknown procedure: laparoscopic.Event description: this complaint was generated from medsun uf/importer report #(b)(4).Model #: ctf03, lot #: 1536652.During the procedure, the view became obstructed and when the camera was removed the surgical team noted that there were small shards of plastic.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.This report is to follow-up medsun uf/importer reports #(b)(4).
Event or Problem Description
Date of event is unknown.Procedure: laparoscopic.Event description: this complaint was generated from medsun uf/importer report # (b)(4).Model #: ctf03, lot #: 1536652.During the procedure, the view became obstructed and when the camera was removed the surgical team noted that there were small shards of plastic.Additional information received from medsun # (b)(4) report via email on 07mar2025: beginning laparoscopic entry into patient abdomen view became obstructed at the muscle layer.Surgery team removed camera and noticed small shards of plastic.Team lead was phoned.Staff in the room obtained new [device name] camera, new trocar and removed old ones from the field.The surgery team irrigated port site/wound then proceeded by creating new port incision above original.Gained entry into the abdomen, assessed original port site and noted they did not completely enter the abdomen of the patient where the defective trocar was placed.Xray at end of case was obtained to ensure no further foreign bodies were present.No further clarification received from user facility, the account reported the same incident twice under # (b)(4) and #(b)(4) due to the matching information.Patient status: no patient injury or illness was reported.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.A historical trend analysis and review of production records was performed, and no relevant documentation was identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is to follow-up medsun uf/importer reports #(b)(4).
Event or Problem Description
Date of event is unknown procedure: laparoscopic.Event description: this complaint was generated from medsun uf/importer report #(b)(4).Model #: ctf03.Lot #: 1536652.During the procedure, the view became obstructed and when the camera was removed the surgical team noted that there were small shards of plastic.Additional information received from medsun #(b)(4) report via email on 07mar2025: beginning laparoscopic entry into patient abdomen view became obstructed at the muscle layer.Surgery team removed camera and noticed small shards of plastic.Team lead was phoned.Staff in the room obtained new [device name] camera, new trocar and removed old ones from the field.The surgery team irrigated port site/wound then proceeded by creating new port incision above original.Gained entry into the abdomen, assessed original port site and noted they did not completely enter the abdomen of the patient where the defective trocar was placed.Xray at end of case was obtained to ensure no further foreign bodies were present.No further clarification received from user facility, the account reported the same incident twice under #(b)(4) due to the matching information.Patient status: no patient injury or illness was reported.

• 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: 21346258
• Report Number: 2027111-2025-00357
• Device Sequence Number: 18380085
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: CTF03
• Device Catalogue Number: 101478835
• Device Lot Number: 1536652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/28/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown