BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSX HANDPIECE

    MDR report key: 2030320 · Received March 21, 2011

    Report

    Report Number
    1811755-2011-00889
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K011381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IN-TRANSIT TO THE U.S. MANUFACTURER, WHERE AN INVESTIGATION WILL BE CONDUCTED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RECEIVED, AND IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVALUATION CONDUCTED BY A MANUFACTURER SERVICE TECHNICIAN, THE MICRODEBRIDER HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSX HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INCL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK