BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAX-CORE DISPOSABLE CORE BIOPSY

    MDR report key: 23927435 · Received December 30, 2025

    Report

    Report Number
    MW5181518
    Event Type
    Other
    Date Received
    December 30, 2025
    Date of Event
    December 12, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRANSPERINEAL PROSTATE BIOPSY ON LISTED PATIENT. THE PRODUCT USED FOR THE PROCEDURE MALFUNCTIONED AND 3 CORE BIOPSY INSTRUMENTS HAD TO BE OPENED TO COMPLETE THE PROCEDURE. PRODUCT REFERENCE NUMBER: MC1825 LOT # REKW0833. PT CODE: 4582. DEVICE CODE: 1069. REF REPORTS: MW5181519, MW5181520.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2638640 MAX-CORE DISPOSABLE CORE BIOPSY INSTRUMENT, BIOPSY KNW BARD PERIPHERAL VASCULAR, INC. REKW0833

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male