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

Model Number	CTF73
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
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 perfomed: open reduction internal fixation (orif) of rib thoracoscopy.Event description: trocar snapped in half.It was a clean break, nothing was left in the patient.No patient injury.The product is available for return.Additional information received from (b)(6) via email on 22aug2024: the device was replaced with a new ctf73 during the case.The procedure being performed was an open reduction internal fixation (orif) of rib thoracoscopy.The break occurred at the shaft of the trocar.The break was identified during the case.The break did not cause particulation.The trocar was not used with a robot.The lot number is 1519892.Intervention: the device was replaced with a new ctf73 during the case.Patient status: no patient injury.
Event or Problem Description
Procedure perfomed: open reduction internal fixation (orif) of rib thoracoscopy.Event description: trocar snapped in half.It was a clean break, nothing was left in the patient.No patient injury.The product is available for return.Additional information received from applied medical representative via email on 22aug2024: the device was replaced with a new ctf73 during the case.The procedure being performed was an open reduction internal fixation (orif) of rib thoracoscopy.The break occurred at the shaft of the trocar.The break was identified during the case.The break did not cause particulation.The trocar was not used with a robot.The lot number is 1519892.Additional information received from applied medical representative via email on 11sep2024: a grasper was in the trocar when it broke.Surgeon moved the trocar against the rib cage which applied pressure to the trocar before breaking.Surgeon inserted trocar properly by rotating in alternating clockwise and counterclockwise.There was no difficulty during insertion.Intervention: the device was replaced with a new ctf73 during the case.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a cannula shaft fracture.The wall thickness of the cannula shaft near the fracture was measured and did not meet specification.Based on the condition of the returned unit, it is likely that the reported event was due to uneven wall thickness of the cannula which could cause the cannula to be more susceptible to fracture when force was applied during the procedure.A historical trend analysis and review of production records was performed and no trends were identified.[correction] sections d1 and d4 (primary unique device identification number and additional unique device identification number) have been updated.

• 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: 20185941
• Report Number: 2027111-2024-00825
• Device Sequence Number: 8363935
• Product Code: GCJ
• UDI-Device Identifier: 00607915123703
• UDI-Public: (01)00607915123703
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 05/06/2025

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: 101219101
• Device Lot Number: 1519892
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GRASPERS
• Patient Sex: Unknown