BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT 2 IMPLANT CARTRIDGE HANDLE KIT

    MDR report key: 23616973 · Received November 21, 2025

    Report

    Report Number
    3015181082-2025-00066
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 20, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020206
    PMA / PMN Number
    K201837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED, AND THE FOLLOWING OBSERVATIONS WERE MADE : THE CARTRIDGE WAS SHIPPED LOOSE (NOT IN A TRAY), THE CARTRIDGE KNOB WAS UNLOCKED, THE PUSHER WAS DEPLOYED, THE CUTTER WAS DEPLOYED, THE SUTURE CRIMP IS INTACT, THE DISTAL TIP WAS UNDAMAGED, A SCOPE SEAL WAS NOT RETURNED WITH THE CARTRIDGE THE ITEMS LISTED ABOVE ARE INDICATORS OF DEVICE STATUS AND ARE AS EXPECTED FOR A DEVICE THAT FUNCTIONED AS DESIGNED. THE FOLLOWING DISCREPANCIES WERE OBSERVED :THE NEEDLE TAB OVERMOLD WAS BOWED, THE SUTURE / SUTURE SUPPORT TUBE WAS BUCKLED, THE URETHRAL ENDPIECE (UE) WAS PRESENT AND DEPLOYED INTO THE SIDE OF THE CAPSULAR TAB (CT), THE CAPSULAR TAB (CT) WAS PRESENT, UNSHEATHED, AND PULLED BACK INTO THE DISTAL TIP (CT PULL THROUGH), NEEDLE DAMAGED : THE NEEDLE IS BROKEN AT THE TIP. THE NEEDLE WAS FOUND TO BE BROKEN APPROXIMATELY 0.63 MM FROM THE TIP. COMPARISON WITH A REFERENCE NEEDLE SHOWS APPROXIMATELY 0.63 MM OF NEEDLE MISSING. THE MISSING NEEDLE MATERIAL WAS NOT RETURNED WITH THE DEVICE. FUNCTIONAL INSPECTION WAS NOT PERFORMED BECAUSE BONE STRIKE IS A DOCUMENTED KNOWN POSSIBLE OUTCOME OF THE UROLIFT PROCEDURE WHICH IS TYPICALLY THE RESULT OF DEVICE POSITIONING OR EXCESSIVE MOVEMENT OF THE DEVICE OR PATIENT ANATOMY. DEVICE HISTORY RECORD REVIEW INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER REPORT OF : " DID NOT FIRE CORRECTLY " WAS CONFIRMED. CONFIRMATION IS BASED ON INTERPRET-ING THE REPORTED EVENT TO MEAN THAT THE RETURNED DEVICE DID NOT CREATE A UROLIFT IMPLANT WITHIN THE PATIENT. THE FAILURE MODE OF BONE STRIKE PREVENTED THE DEVICE FROM CREATING AN IMPLANT. THIS IS A KNOWN POSSIBLE OUTCOME OF THE PROCEDURE AND IS NOT INDICATIVE OF A DEVICE MALFUNCTION. THIS INVESTI-GATION HAS DETERMINED THAT THE DEVICE ENCOUNTERED THE FOLLOWING FAILURE MODES: UL - CT PULL THROUGH: THE CT WAS PRESENT, UNSHEATHED AND PULLED BACK INTO THE DISTAL TIP OF THE DEVICE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR - UNINTENTIONAL - CANNOT DETERMINE. UL - NEEDLE DAMAGED : NEEDLE DAMAGED OCCURS WHEN THE NEEDLE STRIKES BONE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR - UNINTENTIONAL - CANNOT DETERMINE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COM-PLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED " DID NOT FIRE CORRECTLY". ADDITIONAL INFORMATION STATES THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DOING WELL" VIA THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED " DID NOT FIRE CORRECTLY". ADDITIONAL INFOMATION STATES THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DOING WELL" VIA THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511916 UROLIFT 2 IMPLANT CARTRIDGE HANDLE KIT IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC. 73A2500264 10814932020206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.