BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTRACT UROLIFT 2 SYSTEM

    MDR report key: 16473527 · Received March 2, 2023

    Report

    Report Number
    3015181082-2023-00012
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 25, 2023
    Report Date
    March 2, 2023
    Manufacturer
    NEOTRACT, INC.
    Product Code
    PEW
    UDI-DI
    10814932020282
    PMA / PMN Number
    K201837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON 25 JANUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE, IT WAS REPORTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. A PORTION OF THE NEEDLE TIP DETACHED FROM THE DEVICE ADHERED TO THE PATIENT¿S PROSTATIC TISSUE, WHICH WAS REMOVED BY THE PHYSICIAN USING GRASPERS. INVESTIGATION OF THE RETURNED DEVICE AND NEEDLE FRAGMENT ON (B)(6) 2023 IDENTIFIED THAT APPROXIMATELY 2MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED, AND STATED THEY WOULD OBSERVE THE PATIENT¿S CONDITION. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503893 NEOTRACT UROLIFT 2 SYSTEM UROLIFT 2 SYSTEM PEW NEOTRACT, INC. UROLIFT 2 SYSTEM P02435 10814932020282

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male