BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 16247063 · Received January 25, 2023

    Report

    Report Number
    MW5114510
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    January 23, 2023
    Report Date
    January 24, 2023
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEPTUNE BOVIE WAS HANDED OFF THE FIELD TO BE PLUGGED IN. BOVIE WAS PLUGGED IN TO THE OLYMPUS CONSOLE. ONCE IT WAS PLUGGED IN, THE BOVIE JUST STARTED WORKING WHILE IT WAS LAYING ON PT. IT WAS IMMEDIATELY UNPLUGGED. THE SURGEON PICKED BOVIE OFF OF PT AND THE OTHER PLUG WAS USED IN THE OLYMPUS. THE SAME THING OCCURRED, THE BOVIE JUST STARTED WORKING AGAIN. THE BOVIE WAS REMOVED FROM THE FIELD, A NEW ONE WAS OPENED AND WORKED PROPERLY. THE PT DOES HAVE A SMALL BURN ABOVE UMBILICUS NOTED. PRODUCT DESCRIPTION, STRYKER NEPTUNE E-SEP SMOKE EVACUATION PENCIL COATED, 70MM, PUSH BUTTON SWITCH REF# 0703-046-000, LOT# 2120033. REPORTING ON BEHALF OF (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485365 STRYKER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER CORPORATION 2120033

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female