BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET

    MDR report key: 22140205 · Received June 4, 2025

    Report

    Report Number
    22140205
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 20, 2025
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL SUPPLY INOPERABLE. VERSAJET II EXACT HYDROSURGERY SYSTEM HANDPIECE. REPLACED WITH AVAILABLE ALTERNATIVE. REF 66800042, LOT 51278158, EXP 02/21/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627015 VERSAJET LAVAGE, JET FQH SMITH & NEPHEW MEDICAL LTD 66800042 51278158

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown