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

Model Number	CTF01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: diagnostic laparoscopy.Event description: information provided by an applied medical representative via phone (voicemail) on 22dec2025: i got notified that during a diagnostic laparoscopy the ctf01 trocar broke off while using.It broke off mid shaft in the abdomen.We were able to retrieve it.They reported it to their fairview recording system.It broke off in the middle of the procedure not during placement.They had to fish it out.There was no patient injury but there was a post op note that they had to slightly extend the skin incision to remove the trocar piece.Other other then that, no patient harm.They were using a 5mm 0-degree scope and there was no other heat or anything used with it.Additional information provided by an applied medical representative on 23dec2025: yes, broke into patient and retrieved successfully.I am unsure on the details of trocar insertion not used with robot i do not believe it was our obturator that was in cannula during incident.Intervention: opened up another port and completed case.Patient status: patient status is okay.The date of the event is unknown.
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.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not retuned, 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.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: diagnostic laparoscopy.Event description: information provided by an applied medical representative via phone (voicemail) on 22dec2025: i got notified that during a diagnostic laparoscopy the ctf01 trocar broke off while using.It broke off mid shaft in the abdomen.We were able to retrieve it.They reported it to their fairview recording system.It broke off in the middle of the procedure not during placement.They had to fish it out.There was no patient injury but there was a post op note that they had to slightly extend the skin incision to remove the trocar piece.Other than that, no patient harm.They were using a 5mm 0-degree scope and there was no other heat or anything used with it.Additional information provided by an applied medical representative on 23dec2025: yes, broke into patient and retrieved successfully.I am unsure on the details of trocar insertion.Not used with robot.I do not believe it was our obturator that was in cannula during incident.Intervention: opened up another port and completed case.Patient status: patient status is okay.The date of the event is unknown.

• 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: 23962283
• Report Number: 2027111-2026-00300
• Device Sequence Number: 20020175
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: CTF01
• Device Catalogue Number: 101412701
• Device Lot Number: 1563619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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: 5MM 0 DEGREE SCOPE
• Patient Sex: Unknown