BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROLIFT UL400 DELIVERY DEVICE & IMPLANT

    MDR report key: 23556662 · Received November 14, 2025

    Report

    Report Number
    3015181082-2025-00061
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 16, 2025
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932021487
    PMA / PMN Number
    K193269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED, AND THE FOLLOWING OBSERVATIONS WERE MADE: RECEIVED IN TRAY, PUSHER DEPLOYED, CUTTER DEPLOYED, NEEDLE TRIGGER RETRACTED, RETRACT LEVER FULLY RETRACTED, LEVER LOCK AND TAPE DISENGAGED, URETHRAL ENDPIECE (UE) DEPLOYED, DISTAL TIP UNDAMAGED, UNSHEATHING PAWL NOT ENGAGED WITH SUTURE SPOOL, SUTURE UNBUCKLED, SHUTTLE NOT ENGAGED WITH NEEDLE SPOOL, SUTURE FERRULE IN PLACE, CAPSULAR TAB (CT) DEPLOYED, CASE RIGHT UNDAMAGED THE ITEMS LISTED ABOVE ARE INDICATORS OF DEVICE STATUS AND ARE AS EXPECTED FOR A DEVICE THAT FUNCTIONED AS DESIGNED. THE FOLLOWING DISCREPANCY WAS OBSERVED: NEEDLE DAMAGED: THE NEEDLE IS BROKEN AT THE TIP. THE NEEDLE WAS FOUND TO BE BROKEN APPROXIMATELY 1.3MM AND FROM THE TIP. COMPARISON WITH A REFERENCE NEEDLE SHOWS APPROXIMATELY 1.3MM OF NEEDLE MISSING. THE MISSING NEEDLE MATERIAL WAS NOT RETURNED WITH THE DEVICE. MEASURING THE REMAINING SUTURE IN THE DEVICE REVEALED 416MM OF SU-TURE REMAINED. THIS INDICATES A 19MM IMPLANT WERE DELIVERED.THIS IS DERIVED FROM THE FOLLOWING FOR-MULA: IMPLANT DELIVERED = 438 - MEASURED SUTURE LENGTH - 3 MM. TYPICAL IMPLANTED LENGTH IS 5 - 22 MM THE SUTURE CUT QUALITY IS ATYPICAL IN APPEARANCE. THE SUTURE CUT QUALITY WAS OBSERVED TO BE ROUGH WITH SKIVING EXTENDING DOWN THE LENGTH OF THE SUTURE. 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. DE-VICE HISTORY RECORD INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER REPORT OF "SAW A SHINY FLAKE OF WHAT APPEARED TO BE METAL, FLOATING IN THE BLADDER. THIS FLAKE WAS NOT A URETHRAL END PIECE OR CAPSULAR TAB " WAS CONFIRMED. CONFIRMATION IS BASED ON THE INVESTIGATION RESULTS SHOWING THAT THE DEVICE ENCOUNTERED BONE STRIKE WHICH RESULTED IN BROKEN NEEDLE. BONE STRIKE IS A KNOWN POSSIBLE OUTCOME OF THE PROCEDURE AND IS NOT INDICATIVE OF A DEVICE MALFUNCTION. THIS INVESTIGATION HAS DETERMINED THAT THE DEVICE ENCOUNTERED THE FOLLOWING FAILURE MODE(S): UL-NEEDLE DAMAGED: NEEDLE DAMAGE OCCURS WHEN THE NEEDLE STRIKES BONE. THE PROBABLE ROOT CAUSE OF THIS FAILURE MODE IS USE ERROR UNINTENTIONAL- CANNOT DETERMINE. ANALYSIS PERFORMED ON THE RETURNED DEVICES REVEALED THAT THE DEVICE DELIVERED AN APPROXIMATELY 19MM IMPLANT (BASED ON THE SUTURE REMAINING IN THE DEVICE). TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "PERFORMED THE FIRST TWO IMPLANTS AS PER IFU STEPS, WITH SUCCESS. HOWEVER, UPON VISUALISATION, WE COULD SEE THAT THERE WAS A LONG STRAND OF BLUE SUTURE HANGING FROM THE URETHRAL END PIECE. THE IMPLANTS WERE OTHERWISE SATISFACTORY, VERY WELL INVAGINATED INTO THE TISSUE. THE SURGEON IMPLANTED 3 MORE DEVICES, WITH SUCCESS. WHEN HE DID ONE LAST VISUAL CHECK OF THE BLADDER, UPON VISUALISATION, WE SAW A SHINY FLAKE OF WHAT APPEARED TO BE METAL, FLOATING IN THE BLADDER. THIS FLAKE WAS NOT A URETHRAL END PIECE OR CAPSULAR TAB". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "PERFORMED THE FIRST TWO IMPLANTS AS PER IFU STEPS, WITH SUCCESS. HOWEVER, UPON VISUALISATION, WE COULD SEE THAT THERE WAS A LONG STRAND OF BLUE SUTURE HANGING FROM THE URETHRAL END PIECE. THE IMPLANTS WERE OTHERWISE SATISFACTORY, VERY WELL INVAGINATED INTO THE TISSUE. THE SURGEON IMPLANTED 3 MORE DEVICES, WITH SUCCESS. WHEN HE DID ONE LAST VISUAL CHECK OF THE BLADDER, UPON VISUALISATION, WE SAW A SHINY FLAKE OF WHAT APPEARED TO BE METAL, FLOATING IN THE BLADDER. THIS FLAKE WAS NOT A URETHRAL END PIECE OR CAPSULAR TAB". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2851141 UROLIFT UL400 DELIVERY DEVICE & IMPLANT IMPLANTABLE TRANSPROSTATIC TIS PEW NEOTRACT, INC. 73M2400599 10814932021487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown