BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVE CORD

    MDR report key: 3001427 · Received March 7, 2013

    Report

    Report Number
    1519132-2013-00007
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 5, 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

    VISUAL EXAMINATION OF THE RAC-B INSTRUMENT FINDS THAT THE CORD IS COMPLETELY SEVERED JUST PROXIMAL TO THE ELECTRODE CONNECTOR BODY. ALL OF THE WIRES AT THE SEPARATED SECTION OF CORD EXHIBIT SIGNS OF CHARRING AND MELTING AT THE TIP. THE ELECTRODE CONNECTOR BODY WAS RETURNED WITH THE CORD. THE BALANCE OF THE INSULATED WIRE CORD IS IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF ABUSE OR EXCESSIVE WEAR. A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT WITH THE SAME OR SIMILAR VERBIAGE TO THE PROBLEM DESCRIPTION REVEALS THE FOLLOWING ROOT CAUSE: THE MOST LIKELY CAUSE OF THE FAILURE WOULD BE A CUT OR OTHER DAMAGE TO THE CORD IN THE FAILURE REGION, WHICH WOULD LEAD TO AN ELECTRICAL SHORT CONDITION DURING ACTIVATION TO ANY NEARBY GROUNDED OBJECT. THIS SHORT CONDITION WOULD THEN PRODUCE ARCING AND BURNING OF THE WIRES AND INSULATION, RESULTING IN THE ULTIMATE FAILURE OF THE CORD. ALSO, THE IFU UNDER CAUTIONS #4 RESTRICTED SERVICE LIFE - DO NOT USE THE CABLE FOR A PERIOD OF MORE THAN ONE YEAR. USING THE CABLE BEYOND ONE YEAR MAY BE HAZARDOUS.

    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, UPON ACTIVATION OF THE ACTIVE CORD RAC-B, SMOKE WAS NOTICED, AND THEN A SMALL BURST OF FLAME THAT WAS IMMEDIATELY EXTINGUISHED. UPON EXAMINATION, THE USER FACILITY REPORTED THAT THE CORD APPEARED FATIGUED JUST BELOW THE STRAIN RELIEF WHERE THE CABLE CONNECTOR ATTACHES TO THE RESECTOSCOPE. NO ONE WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96720 ACTIVE CORD ACTIVE CORD HIH GYRUS ACMI, INC. RAC-B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK