BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET II CONSOLE

    MDR report key: 9661590 · Received February 3, 2020

    Report

    Report Number
    8043484-2020-00084
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 16, 2020
    Report Date
    December 10, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    FQH
    PMA / PMN Number
    K110958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION OF DEBRIDEMENT UTILIZING A VERSAJET, THE HAND-PIECE SALINE PRESSURE WAS WEAK AND SALINE LEAKAGE OCCURRED FROM THE ORANGE CARTRIDGE WHEN PRIMING SALINE. THE SURGERY WAS COMPLETED WITH SURGICAL KNIFE. NO PATIENT HARM. NO DELAY IN TREATMENT. AFTER INSPECTION, THE CONSOLE WILL BE RETURNED TO OKC IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125284 VERSAJET II CONSOLE LAVAGE, JET FQH SMITH & NEPHEW MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1