BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KII FIOS FIRST ENTRY

    MDR report key: 23280062 · Received October 15, 2025

    Report

    Report Number
    2027111-2025-00806
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    January 21, 2026
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915119874
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791628 KII FIOS FIRST ENTRY LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CFF33 1554010 00607915119874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown