BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSX HANDPIECE

    MDR report key: 2132287 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02113
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K011381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POLYPS REMOVAL SURGERY, THE POWER WAS INCREASED TO 5000 RPM; THE DEVICE GOT VERY HOT. THE SURGERY WAS FINISHED WITHOUT THE HANDPIECE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSX HANDPIECE ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK