BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENEVA

    MDR report key: 23253549 · Received October 9, 2025

    Report

    Report Number
    9611894-2025-00002
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    August 5, 2025
    Report Date
    November 7, 2025
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    PMA / PMN Number
    K201272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Additional Manufacturer Narrative · 0

    H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. ON (B)(6) 2025, THE TIP OF AN INTRAUTERINE TUBE FROM THE GENEVA APPLICATOR WAS FOUND TO BE MISSING, UPON REMOVAL OF THE APPLICATOR FROM THE PATIENT. THE CUSTOMER INFORMED ELEKTA THAT ATTEMPTS WERE MADE TO LOCATE (USING IMAGING) AND REMOVE (MEDICAL INTERVENTION) THE TIP FROM THE UTERUS. THE TIP WAS NOT SUCCESSFULLY RETRIEVED. THE INVESTIGATION FOUND THAT THE PPSU PLUG USED IN IU-TUBES (4MM) FOR CT/MR APPLICATORS CAN GET DETACHED FROM THE FIBER TUBE. THE ROOT CAUSE HAS BEEN IDENTIFIED TO BE: THE FAILURE OF THE ADHESIVE JOINT AND THE SUBSEQUENT DETACHMENT OF THE PLUG FROM THE TUBE AFTER REPEATED STEAM STERILIZATION CYCLES ARE CAUSED DUE TO COMBINATION OF TWO FACTORS: 1. THE PRESENCE OF SMALL CRACKS IN THE FIBER TUBES MATERIAL, EXPOSING THE GLASS FIBERS TO STEAM DURING STERILIZATION. 2. AN INADEQUATE SPECIFICATION AND APPLICATION OF THE EPOXY ADHESIVE BETWEEN THE PLUG AND THE INNER AND END SURFACES OF THE TUBE. ELEKTA PERFORMED A RISK ASSESSMENT AND ASSESSED THE HIGHEST SEVERITY OF HARM TO BE "SERIOUS" AND PROBABILITY TO BE "REMOTE". THE RISK ASSESSMENT CONCLUDED THAT THE RISK IS CONSIDERED MEDIUM. NEW MANUFACTURING RISKS HAVE BEEN IDENTIFIED: FAILURE MODE 1: TIP / PLUG DETACHED DURING TREATMENT OR DURING APPLICATOR REMOVAL, DUE TO CRACKS IN GLASS FIBER TUBE IN1.COMBINATION WITH INADEQUATE GLUING OF TIP (PLUG) TIP / PLUG REMAINS INSIDE PATIENT SEVERITY OF HARM (WORST-CASE): SERIOUS PROBABILITY OF OCCURRENCE OF HARM: REMOTE RISK LEVEL: MEDIUM ASSOCIATED HARM (WORST-CASE): 'FOREIGN BODY LOCATED IN PATIENT'S BODY REQUIRING A MEDICAL INTERVENTION' FAILURE MODE 2: TIP / PLUG DETACHED DURING TREATMENT OR DURING APPLICATOR REMOVAL, DUE TO CRACKS IN GLASS FIBER TUBE IN2.COMBINATION WITH INADEQUATE GLUING OF TIP (PLUG); OPEN END IN APPLICATOR CHANNEL CONTAMINATION IN APPLICATOR SOURCE PATH (INNER LUMEN, TRANSFER TUBE, SOURCE, AFTERLOADER), RESULTING IN CONTAMINATION OF NEXT PATIENT(S) SEVERITY OF HARM: NON-SERIOUS PROBABILITY OF OCCURRENCE OF HARM: IMPLAUSIBLE RISK LEVEL: LOW. THE FOLLOWING MEASURES HAVE BEEN IMPLEMENTED: IMPROVEMENT OF THE GLUING PROCEDURE. INCREASED VISUAL INSPECTION TO ENSURE THE TUBE IS FREE OF DAMAGE AND ADHESIVE COVERAGE IS COMPLETE AND UNIFORM.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A BROKEN INTRAUTERINE TUBE; THE TIP IS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2509011 GENEVA INTRAUTERINE TUBE 50MM 30° JAQ NUCLETRON B.V. 1000269785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O