BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE CORD

    MDR report key: 3001410 · Received March 7, 2013

    Report

    Report Number
    1519132-2013-00006
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EVAL. 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

    GYRUS ACMI WAS INFORMED THAT DURING A THERAPEUTIC ENDOMETRIAL ABLATION PROCEDURE, THE CAUTERY CORD ON THE RESECTOSCOPE CAME APART. THE USER FACILITY REPORTED THAT AT THE BEGINNING OF THE PROCEDURE THAT THERE WAS SMOKE WHICH LEAD TO FLAMES THAT NEEDED TO BE EXTINGUISHED. UPON EXAM, THE USER FACILITY REPORTED THAT THE CORD APPEARED FATIGUED JUST BELOW THE STRAIN RELIEF WHERE THE CABLE CONNECTOR ATTACHES TO THE RESECTOSCOPE. NO PT INJURY WAS REPORTED. THE USER FACILITY REPORTED THAT THE PHYSICIAN FELT A "TINGLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97784 ACTIVE CORD ACTIVE CORD HIH GYRUS ACMI, INC. RAC-B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK