BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAJET

    MDR report key: 8840877 · Received July 30, 2019

    Report

    Report Number
    8840877
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    June 24, 2019
    Report Date
    June 26, 2019
    Manufacturer
    SMITH NEPHEW MEDICAL LIMITED
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VERSAJET II PLUS HYDROSURGERY 15 DEGREE/14MM HANDPIECE WAS UTILIZED FOR ISCHIAL DEBRIDEMENT CASE AND WHEN SURGEON WAS PRIMING HANDPIECE ON STERILE FIELD, DEVICE MALFUNCTIONED AND STAINLESS STEEL WIRE DISENGAGED/EXPLODED FROM KEY SYSTEM IN VERSAJET CONSOLE; NO PATIENT OR STAFF HARM BUT DEVICE WAS KEPT AND GIVEN TO OPERATING ROOM MANAGEMENT FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635393 VERSAJET LAVAGE, JET FQH SMITH NEPHEW MEDICAL LIMITED 66800043 50705929

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA