BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIEGO FOOTSWITCH

    MDR report key: 3062875 · Received April 12, 2013

    Report

    Report Number
    1037007-2013-00003
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ERL
    PMA / PMN Number
    K020594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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, (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE DIEGO, THE SURGEON CLAIMED HE REMOVED HIS FOOT FROM THE FOOT PEDAL, BUT THE BLADE KEPT GOING. IN TURN, THE PATIENT'S UVULA WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157458 DIEGO FOOTSWITCH DIEGO FOOTSWITCH ERL GYRUS ACMI, INC. 70338011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other