BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTEON

    MDR report key: 22318042 · Received June 24, 2025

    Report

    Report Number
    22318042
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    June 19, 2025
    Report Date
    June 19, 2025
    Manufacturer
    SATELEC-ACTEON GROUP
    Product Code
    JDX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PIEZOTOME REUSABLE TIP BROKE OFF THE HANDPIECE WHILE BEING REMOVED WITH THE WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579714 ACTEON INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT JDX SATELEC-ACTEON GROUP RHS1 M+ N STER TIP 605099_1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male