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

Model Number	CFF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: laparoscopic gyn.Surgery.Event description: umbilicus - first entry, first trocar inserted.After use of verres needle cff 33, kii fios first entry lot nr, 1554010 so far, this is what i know by email.I will contact the hospital tomorrow, about more information.Like what kind of procedure and how it happened.Additional information received from applied medical representative via pcf on 30sep2025: the incidence occurred when inserting the trocar in umbilicus.They used verres needle to insufflate the abdomen before inserting and the tip broke when inserting.The incidence was reported as an irregularity accident at the department.The nurse that received the information was not in place and the incidence was reported 18/9 with no further explanation than i have explained.The event is described as good as possible.This incident has happened earlier this year also, and it might be that there are surgeons in this huge department that have to be taught or reminded how to insert applied kii fios first entry trocar with separating tip in the right manner.I will take care of this! they picked small pieces of the trocar from inside of the abdomen and then changed to a new trocar.It was only the camera inside and the grasper had to pick up the pieces.Additional information received from applied medical representative via email on 03oct2025: unfortunately, cannot confirm where the break occurred (cannula/obturator), the information was in a report that the nurse received several days after the incidence.No information on how the trocar was inserted and regarding the difficulty in insertion.This trocar was not used with a robot.The obturator inserted in the cannula at the time of the incident.No image available.Intervention: they picked small pieces of the trocar from inside of the abdomen and then changed to a new trocar.Patient status: patient was not harmed by the incidence.
Additional Manufacturer Narrative
The event unit is not being returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
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.A historical trend analysis and review of production records was performed, and no trends were identified.
Event or Problem Description
Procedure performed: laparoscopic gyn.Surgery event description: umbilicus - first entry, first trocar inserted.After use of verres needle cff 33, kii fios first entry lot nr, 1554010 so far, this is what i know by email.I will contact the hospital tomorrow, about more information.Like what kind of procedure and how it happened.Additional information received from applied medical representative via pcf on 30sep2025: the incidence occurred when inserting the trocar in umbilicus.They used verres needle to insufflate the abdomen before inserting and the tip broke when inserting.The incidence was reported as an irregularity accident at the department.The nurse that received the information was not in place and the incidence was reported 18/9 with no further explanation than i have explained.The event is described as good as possible.This incident has happened earlier this year also, and it might be that there are surgeons in this huge department that have to be taught or reminded how to insert applied kii fios first entry trocar with separating tip in the right manner.I will take care of this! they picked small pieces of the trocar from inside of the abdomen and then changed to a new trocar.It was only the camera inside and the grasper had to pick up the pieces.Additional information received from applied medical representative via email on 03oct2025: unfortunately, cannot confirm where the break occurred (cannula/obturator), the information was in a report that the nurse received several days after the incidence.No information on how the trocar was inserted and regarding the difficulty in insertion.This trocar was not used with a robot.The obturator inserted in the cannula at the time of the incident.No image available.Intervention: they picked small pieces of the trocar from inside of the abdomen and then changed to a new trocar.Patient status: patient was not harmed by the incidence.

• 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: 23280062
• Report Number: 2027111-2025-00806
• Device Sequence Number: 20223723
• Product Code: GCJ
• UDI-Device Identifier: 00607915119874
• UDI-Public: (01)00607915119874
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: CFF33
• Device Catalogue Number: 101477566
• Device Lot Number: 1554010
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown