BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6364691 · Received February 28, 2017

    Report

    Report Number
    2951238-2017-00132
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 28, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS DUE TO USER HANDLING. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE CABLE. ¿VISUALLY INSPECT THE CABLE AND THE PLUGS FOR IRREGULARITIES ON THE SURFACE. DO NOT USE A CABLE WITH BRITTLE OR DEFECTIVE INSULATION. REPLACE THE CABLE. IN ORDER TO PLUG OR UNPLUG THE CABLE, ALWAYS PULL AT THE PLUG. NEVER PULL AT THE CABLE OR RISK OF DAMAGING THE CABLE MAY OCCUR.¿ ALSO, ¿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.¿ IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED FOR EVALUATION, THIS REPORT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE HF-CABLE SPARKED AND FAILED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR HF CABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148708 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, HF CABLE GCJ OLYMPUS WINTER & IBE GMBH A0393 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1