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

Model Number	CTF73
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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: lavh (event occurred before use).Event description: the trocar was opened to the sterile field.As the obturator was placed into the cannula, a plastic clip on the side of the seal detached.This is one of two clips that lock the seal housing in place on the cannula.The trocar was opened in a normal manner.It was not "flipped" onto the table.No clinical impact to the patient as a result of the event.The unit was never passed to the surgeon for use.Additional information provided by applied medical representative on 02may2025: the color of the piece was clear.No internal seal components were removed or cut to inspect the damaged component.The entire seal housing and the cap did not detach.The tabs were not being pinched at the time of breakage.I was there when it was opened to the back table.The tech took the trocar, and when she went to assemble it (put the obturator in the canula) a clear piece of plastic fell off of the canula.Upon inspection it was one of the clips that clip the cannula onto the seal housing.The broken piece and the trocar have been shipped back to you.Intervention: opened another ctf73 and continued the case.Patient status: no patient status provided, event occurred before use.
Event or Problem Description
Procedure performed: lavh (event occurred before use) event description: the trocar was opened to the sterile field.As the obturator was placed into the cannula, a plastic clip on the side of the seal detached.This is one of two clips that lock the seal housing in place on the cannula.The trocar was opened in a normal manner.It was not "flipped" onto the table.No clinical impact to the patient as a result of the event.The unit was never passed to the surgeon for use.Additional information provided by applied medical representative on 02may2025: the color of the piece was clear.No internal seal components were removed or cut to inspect the damaged component.The entire seal housing and the cap did not detach.The tabs were not being pinched at the time of breakage.I was there when it was opened to the back table.The tech took the trocar, and when she went to assemble it (put the obturator in the canula) a clear piece of plastic fell off of the canula.Upon inspection it was one of the clips that clip the cannula onto the seal housing.The broken piece and the trocar have been shipped back to you.Intervention: opened another ctf73 and continued the case.Patient status: no patient status provided, event occurred before use.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a broken cannula wing tab.Based on the condition of the returned unit; it is possible that the damage to the cannula wing tab occurred due to improper handling.However, the exact root cause of the broken cannula wing tab could not be determined.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: 21961898
• Report Number: 2027111-2025-00509
• Device Sequence Number: 15272070
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: CTF73
• Device Catalogue Number: 101478837
• Device Lot Number: 1537981
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• 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 Sex: Unknown