BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 6015589 · Received October 10, 2016

    Report

    Report Number
    0001811755-2016-02544
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE USER FACILITY PRIOR TO THE START OF A SURGICAL PROCEDURE THE END OF THE POWER CORD SPARKED. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665336 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1