BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSX HANDPIECE

    MDR report key: 2082087 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01336
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K011381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICRODEBRIDER WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND IT WAS DISCOVERED THAT THE MOTOR FAILED DUE TO A WIRE DISCONNECTION, WHICH RESULTED IN HEAT BEING GENERATED WHEN THE DEVICE WAS OPERATED. THE MOTOR ASSEMBLY WAS REPLACED AND ADDITIONAL PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY THE MANUFACTURER SALES REPRESENTATIVE, THE MICRODEBRIDER HEATED UP. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, 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 ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK