BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET EXACT HYDROSURGERY

    MDR report key: 2924758 · Received January 8, 2013

    Report

    Report Number
    2924758
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 8, 2013
    Manufacturer
    SMITH & NEPHEW
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING A REVISION OF LEFT FOOT AMPUTATION, SURGEON REQUESTED THE USE OF THE VERSAJET HYDROSURGERY SYSTEM. THE BASE MOTOR WAS BROUGHT INTO THE OR AND THE DISPOSABLE HANDPIECE SYSTEM WAS DELIVERED TO THE FIELD. THE APPROPRIATE TUBING AND INSTRUMENT WERE PASSED OFF THE FIELD TO THE CIRCULATOR AND ATTACHED TO THE MOTOR. THE HANDPIECE DID NOT FUNCTION APPROPRIATELY (WATER WAS SPEWING UNCONTROLLABLY AT ALL SETTINGS). ATTEMPT AT RE-CONNECTION WAS COMPLETED WITH THE SAME RESULT. A NEW HANDPIECE SYSTEM WAS OPENED, DELIVERED TO THE FIELD AND CONNECTED. THIS INSTRUMENTATION WORKED CORRECTLY. THE PROCEDURE WAS COMPLETED. NO HARM CAME TO THE PATIENT.SPECIFIC INFO: SMITH & NEPHEW VERSAJET EXACT HYDROSURGERY SYSTEM HANDPIECE.45 DEGREE ANGLE,8MM BLADE,REF # 50637.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8687 VERSAJET EXACT HYDROSURGERY LAVAGE, JET, HANDPIECE FQH SMITH & NEPHEW * 07212MK

    Patients

    Seq Age Sex Outcome Treatment
    1 *