BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET

    MDR report key: 22282743 · Received June 18, 2025

    Report

    Report Number
    22282743
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 10, 2025
    Report Date
    June 11, 2025
    Manufacturer
    SMITH NEPHEW MEDICAL LIMITED
    Product Code
    FQH
    UDI-DI
    00040565124681
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PREPARING TO START SURGICAL PROCEDURE THE VERSAJET HYDROSURGERY HANDPIECE WAS SET UP FOR USE, YET WHEN THE TEAM WENT TO PRIME THE TUBING FOR SURGEON USE IT DID NOT INITIATE THIS PROCESS. SURGICAL TEAM OBTAINED A NEW HANDPIECE WITH NO ISSUE. HANDPIECE SAVED. REF # 66800041, LOT#(10)51287320, EXP: 2/19/2027, MANUFACTURER :SMITH AND NEPHEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853173 VERSAJET LAVAGE, JET FQH SMITH NEPHEW MEDICAL LIMITED 66800041 (10)51287320 00040565124681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown