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

Model Number	CTF73
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy event description: event date: (b)(6) 2024 model #: ctf73 [hospital name] in [city and state] utilized one of our ctr03 trocars on saturday, october 12th.The trocar trial was to start on 10/14, but the surgeon utilized without our knowledge.During education table, she claimed to have prior experience with them.Dr.[name] found that the ¿cheap plastic diaphragm makes it difficult to pass clips and tears easily, scattering bits of plastic in the patient.I had to retrieve two pieces of plastic on my lap chole today and have photos of the plastic and of the torn-up diaphragm of the trocar with missing pieces of plastic from routine instrument passing of a clip applier." the physician also stated that the optical tip had an inferior tip, making it unsafe due to poor visibility.The trocar walls don¿t grip tissue and slide in/out.Product cannot be located and will not return.Additional information obtained from applied representative on 15oct2024: the pieces of the trocar that broke off were removed laparoscopically.The patient is fine.The procedure was completed by replacing with [competitor device] 12mm trocar.No internal seal components were removed or cut in order to inspect the damaged component.The doctor used a large, reposable 10mm clip applier with a loaded metal clip and entered it through our (applied) 12mm trocar.Intervention: replaced with ethicon 12mm trocar to complete procedure patient status: patient is fine.
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of investigation.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided, confirming the complainant¿s experience of a damaged septum.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.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 cholecystectomy.Event description: event date: 14oct2024.Model #: ctf73.[hospital name] in [city and state] utilized one of our ctr03 trocars on (b)(6).The trocar trial was to start on 10/14, but the surgeon utilized without our knowledge.During education table, she claimed to have prior experience with them.Dr.[name] found that the ¿cheap plastic diaphragm makes it difficult to pass clips and tears easily, scattering bits of plastic in the patient.I had to retrieve two pieces of plastic on my lap chole today and have photos of the plastic and of the torn-up diaphragm of the trocar with missing pieces of plastic from routine instrument passing of a clip applier." the physician also stated that the optical tip had an inferior tip, making it unsafe due to poor visibility.The trocar walls don¿t grip tissue and slide in/out.Product cannot be located and will not return.Additional information obtained from applied representative on 15oct2024: the pieces of the trocar that broke off were removed laparoscopically.The patient is fine.The procedure was completed by replacing with [competitor device] 12mm trocar.No internal seal components were removed or cut in order to inspect the damaged component.The doctor used a large, reposable 10mm clip applier with a loaded metal clip and entered it through our (applied) 12mm trocar.Intervention: replaced with ethicon 12mm trocar to complete procedure.Patient status: patient is fine.

• 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: 20636374
• Report Number: 2027111-2024-00898
• Device Sequence Number: 18019134
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/28/2025

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
• Was Device Available for Evaluation?: No
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REPOSABLE 10MM CLIP APPLIER WITH LOADED METAL CLIP
• Patient Sex: Unknown