BEUDAMED
    FDA Enforcement Class II Ongoing

    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO

    Recall: Z-2364-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2364-2023
    Event ID
    92700
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Scholly Fiberoptic Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 16, 2023
    Initiation Date
    June 23, 2023
    Classification Date
    August 9, 2023
    Address
    Robert-Bosch-Str. 1-3, N/A, Denzlingen, N/A, N/A, Germany

    Description

    UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into the bladder. Model: UL-VO

    Reason

    There is an improperly performed weld between the cone of the sheath lock and tube of the obturator; mechanical load capacity is impaired, and fracture of the welded joint may occur. Contamination can occur in this capillary gap, which is not covered by the reprocessing validations performed.

    Code Info

    UDI-DI: 04250480106617 Lot Number: 141980

    Distribution

    Nationwide Foreign: Japan, South Korea

    Quantity

    98 units