BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC

    MDR report key: 1013606 · Received March 14, 2008

    Report

    Report Number
    1811755-2008-00014
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS POSSIBLE THAT THE CLEANING OF THE DEVICE IS WHAT CAUSED THE REPORTED SYMPTOMS TO THESE TWO EMPLOYEES, HOWEVER, THE FIELD TECH DID NOT EXPERIENCE ANY OF THESE SYMPTOMS.

    Description of Event or Problem · 1

    FIELD TECH WAS DECOMMISSIONING NEPTUNE UNITS USING A BLEACH CLEANING PROTOCOL IN ORDER TO TRANSPORT THE UNITS. IT WAS REPORTED THAT TWO HOSPITAL EMPLOYEES EXPERIENCED IRRITATED EYES, SORE THROAT AND WHEEZING FROM THE FUMES OF THE BLEACH. BOTH EMPLOYEES WERE SENT TO THE ER WITH THESE SYMPTOMS, BUT IT IS NOT KNOWN WHAT TYPE OF TREATMENT, IF ANY, WAS PROVIDED IN THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC APPARATUS, SURGICAL, EXHAUST FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK