BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET II CONSOLE

    MDR report key: 11036305 · Received December 18, 2020

    Report

    Report Number
    8043484-2020-04314
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    March 22, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQH
    UDI-DI
    04582111153524
    PMA / PMN Number
    K143115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED FAILURE HAPPENED ON A VERSAJET II DEVICE. IT IS UNKNOWN IF HAPPENED DURING TREATMENT OR UPON INSPECTION. IT WAS STATED THAT THE HOSPITAL CLOSED. DURING A PRELIMINARY EVALUATION BY S+N, IT WAS FOUND THAT THE U.I. ASSEMBLY WAS CORRODED, SO THE HANDPIECE DID NOT LOCK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506575 VERSAJET II CONSOLE LAVAGE, JET FQH SMITH & NEPHEW MEDICAL LTD. KWHL170011 04582111153524

    Patients

    Seq Age Sex Outcome Treatment
    1