BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIEGO CONSOLE TRIGGER ENABLED

    MDR report key: 3122010 · Received May 16, 2013

    Report

    Report Number
    1037007-2013-00004
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ERL
    PMA / PMN Number
    K020594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY. THE FACILITY INDICATED THAT THEY WILL NOT BE RETURNING THE DEVICE, THERE IS NOTHING WRONG WITH IT, THE SURGEON RAN IT TOO LONG WITHOUT A PAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUS (B)(4) THAT DURING A SURGICAL PROCEDURE THE HAND PIECE OVERHEATED. IT WAS INDICATED THAT THEY WERE RUNNING THE HAND PIECE TOO LONG WITHOUT PAUSE AND IT OVERHEATED. THERE WAS NO PATIENT INJURY OR SURGEON INJURY. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER INCIDENTS. THEY HAVE TAKEN IT UNDER ADVISEMENT TO NOT RUN THE DEVICE WITHOUT A PAUSE AND HAVE NOT HAD THIS PROBLEM SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216900 DIEGO CONSOLE TRIGGER ENABLED DIEGO CONSOLE TRIGGER ENABLED ERL GYRUS ACMI, INC. 70339000

    Patients

    Seq Age Sex Outcome Treatment
    1