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

Model Number	CTF71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: robotic hysterectomy.Event description: we used a ctf71 trocar and the trocar broke in half.Additional information obtained from hospital representative via email on 13nov2024.No patient injury or illness occurred.The patient had o-obp- 24-hour observation.The procedure was a robotic hysterectomy.Other devices used alongside ctf71 were ctf03 and ctf34.Lot trace was performed using account associated with the hospital (b)(6).Additional information obtained from hospital representative via email on 13nov2024.The event date is april 27, 2017.Additional information obtained from hospital representative via email on 18nov2024.The trocar broke during the 2017 case and it was not realized by the staff in 2017.The patient returned to surgery this year on (b)(6), and it was discovered in her abdomen.Additional information obtained from hospital representative via email on 25nov2024.The surgery on (b)(6) 2024 was unrelated to the trocar being left inside.Patient status: no patient injury or illness occurred, o-opb - 24 hour observation.
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.
Event or Problem Description
Procedure performed: robotic hysterectomy.Event description: we used a ctf71 trocar and the trocar broke in half.Additional information obtained from hospital representative via email on (b)(6) 2024 no patient injury or illness occurred.The patient had o-obp- 24-hour observation.The procedure was a robotic hysterectomy.Other devices used alongside ctf71 were ctf03 and ctf34.Lot trace was performed using account associated with the hospital- (b)(6) additional information obtained from hospital representative via email on (b)(6) 2024 the event date is april 27, 2017.Additional information obtained from hospital representative via email on (b)(6) 2024 the trocar broke during the 2017 case and it was not realized by the staff in 2017.The patient returned to surgery this year (b)(6), and it was discovered in her abdomen.Additional information obtained from hospital representative via email on (b)(6) 2024 the surgery on (b)(6) 2024 was unrelated to the trocar being left inside.Patient status: no patient injury or illness occurred, o-opb - 24 hour observation.
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.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 20789182
• Report Number: 2027111-2024-00930
• Device Sequence Number: 7809926
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: CTF71
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 05/16/2025
• 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
• Patient Sex: Unknown