BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUSABLE ACTIVE CORD

    MDR report key: 1884160 · Received October 14, 2010

    Report

    Report Number
    1519132-2010-00030
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    August 25, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED AT THIS TIME. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A TRANSURETHERAL RESECTION BLADDER PROCEDURE, THE SURGEON RECEIVED A SMALL DEEP BURN TO THE LEFT FOREARM FROM THE ACTIVE CORD. THE BURN WAS TREATED TOPICALLY AND RESOLVED. NO FURTHER INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE ACTIVE CORD ACTIVE CORD HIH GYRUS ACMI, INC. RAC-B

    Patients

    Seq Age Sex Outcome Treatment
    1