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)
Date of Event	10/02/2024
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 performed: unknown (robotic).Event description: we would like to report an incident the or on weds 10/2 with the kii fios first entry # (b)(4).During a case, the tip broke (lot# 1492323) in a patient while in use.According to the report, staff were able to retrieve the broken pieces.We reviewed our current on hand inventory and found no product with the same lot number.Additional information provided by applied medical representative on 07oct2024 via email: i was able to speak with the cno this afternoon and he stated that the incident was user error.A resident was trying to insert the trocar into the abdomen and hit the scope upon entry causing the tip to break off.The case was robotic¿ it was a general case but following up to confirm the exact case.No concomitant devices were being used.The trocar was inserted in rotation.There was no difficult during insertion and the robot was not used directly but as an ancillary port.The obturator was inserted in the cannula at the time of the incident.Intervention: staff were able to retrieve the broken pieces.Patient status: no patient injury or illness was reported.
Event or Problem Description
Procedure performed: unknown (robotic).Event description: we would like to report an incident the or on weds 10/2 with the kii fios first entry # ctf03.During a case, the tip broke (lot# 1492323) in a patient while in use.According to the report, staff were able to retrieve the broken pieces.We reviewed our current on hand inventory and found no product with the same lot number.Additional information provided by applied medical representative on 07oct2024 via email: i was able to speak with the cno this afternoon and he stated that the incident was user error.A resident was trying to insert the trocar into the abdomen and hit the scope upon entry causing the tip to break off.The case was robotic¿ it was a general case but following up to confirm the exact case.No concomitant devices were being used.The trocar was inserted in rotation.There was no difficult during insertion and the robot was not used directly but as an ancillary port.The obturator was inserted in the cannula at the time of the incident.Intervention: staff were able to retrieve the broken pieces.Patient status: no patient injury or illness was reported.
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 fractured obturator tip.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.[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: 20412576
• Report Number: 2027111-2024-00865
• Device Sequence Number: 8380905
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/02/2025

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 Expiration Date: 05/17/2026
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1492323
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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