BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET

    MDR report key: 14287801 · Received May 5, 2022

    Report

    Report Number
    14287801
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 1, 2022
    Manufacturer
    SMITH NEPHEW MEDICAL LIMITED
    Product Code
    FQH
    UDI-DI
    00040565124681
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    VERSAJET DEVICE HAD BEEN USED FOR APPROXIMATELY 30 MINUTES WITHOUT ISSUE; HOWEVER DURING PRIMING, SURGEONS DESCRIBE THE DEVICE "WAS GOING FASTER AND FASTER" WITHOUT CHANGING ANY SETTINGS, AND THE DEVICE MADE A LOUD POP NOISE, AND THE CABLES POPPED OFF AND SEPARATED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097811 VERSAJET LAVAGE, JET FQH SMITH NEPHEW MEDICAL LIMITED 66800041 50992957 00040565124681

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Male