BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6050029 · Received October 24, 2016

    Report

    Report Number
    2951238-2016-00812
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 23, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION; HOWEVER, A PHOTOGRAPHIC IMAGE OF THE CORD WAS PROVIDED BY THE USER FACILITY. THE IMAGE ILLUSTRATED THAT CORD WAS SEPARATED FROM THE CONNECTOR. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BUT WITH NO RESULT. THE MOST LIKELY CAUSE FOR THE REPORTED EVENT IS DUE 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 AN UNSPECIFIED PROCEDURE, THE HF-CABLE AND THE DRAPE ON THE PATIENT CAUGHT FIRE. IT WAS REPORTED THAT THE FIRE STARTED BEHIND THE BANANA PLUG (CONNECTION POINT) WHILE IN USE WITH A NON-OLYMPUS GENERATOR. THE FIRE WAS DISTINGUISHED WITH NO USER OR PATIENT INJURY. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. ADDITIONALLY, THE USER FACILITY REPORTED THAT HF-CABLE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701634 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, HF-CABLE GCJ OLYMPUS WINTER & IBE GMBH A0393 307574

    Patients

    Seq Age Sex Outcome Treatment
    1 VALLEY LAB FORCE FX GENERATOR