BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE & USA COLD KNIFE STRAIGHT BLADE

    MDR report key: 3952123 · Received November 26, 2013

    Report

    Report Number
    1519132-2013-00039
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    September 18, 2013
    Report Date
    October 29, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    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 ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GYRUSACMI VIA A UF MEDWATCH (B)(4) THAT DURING AN OPTICAL URETHROTOMY PORTION OF THE PROCEDURE, THE KNIFE TIP ON THE URETHROTOME BROKE AND REMAINED IN THE TISSUE. THE SURGEON REMOVED THE KNIFE IN ITS ENTIRETY FROM THE PATIENT'S TISSUE. THERE WAS NO HARM TO THE PATIENT. AN X-RAY WAS TAKEN AND READ AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617484 ELITE & USA COLD KNIFE STRAIGHT BLADE COLD KNIFE STRAIGHT BLADE FJL GYRUS ACMI, INC. K-SB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention