BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR, 4 M, UES-30/-40,

    MDR report key: 6115498 · Received November 19, 2016

    Report

    Report Number
    2951238-2016-00874
    Event Type
    Malfunction
    Date Received
    November 19, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. BASED ON PREVIOUS INVESTIGATIONS THE MOST LIKELY CAUSE FOR THE REPORTED EVENT CAN BE ATTRIBUTED TO USER HANDLING. THE INSTRUCTION MANUAL GIVES SEVERAL WARNING TO PREVENT THIS TYPE OF CORD DAMAGE. ¿DO NOT USE A CABLE WITH BRITTLE OR DEFECTIVE INSULATION. REPLACE THE CABLE. VISUALLY INSPECT THE CABLE AND THE PLUGS FOR IRREGULARITIES ON THE SURFACE. WHEN USED AS INTENDED THIS PRODUCT IS MORE OR LESS SUBJECT TO WEAR DEPENDING ON THE INTENSITY OF USE. DO NOT USE THE HF CABLE AFTER ONE YEAR OF USE. IN CASE A PRODUCT HAS EXTERNALLY VISIBLE DEFECTS CONTACT THE RESPONSIBLE OLYMPUS REPRESENTATIVE AT ONCE.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC HYSTERON ABLATION PROCEDURE, THE SURGICAL STAFF HEARD A POP SOUND AND OBSERVED A SPARK AND A SMALL FLAME ON THE HF-CORD AS IT BLEW APART AT THE CONNECTION SITE ON THE WORKING ELEMENT. THE GENERATOR SETTINGS WERE COAG 100/CUT 100. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONALLY, IT WAS REPORTED THAT THE THERE WERE NO NOTICEABLE DEFECTS IN THE CORD DURING SETUP. IT IS UNKNOWN IF THE CONNECTION PORT WAS INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766526 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, HF-CORD GCJ OLYMPUS WINTER & IBE GMBH A0393 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 A22258C ELECTRODE/LOT#UNK| ESU GENERATOR/SN.UNK| WA22067A WORKING ELEMENT /SN. UNK