BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6298807 · Received February 2, 2017

    Report

    Report Number
    2951238-2017-00054
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    October 27, 2016
    Report Date
    June 9, 2017
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE HF CABLE FOUND THE INSULATION CABLE IS SPLIT AT THE HF CONNECTOR. THE INTERNAL WIRES WERE EXPOSED. A MICROSCOPE INSPECTION WAS PERFORMED AND REVEALED BURN MARKS ON THE INTERNAL ELEMENTS. IN ADDITION, THE CABLE INSULATION WAS NOTED TO BE BUCKLED/KINKED BELOW THE PROTECTIVE BOOT COVER OF THE HF CONNECTOR PLUG SIDE. THE EVALUATION COULD NOT PERFORM ELECTRICAL DUE TO THE AS RECEIVED CONDITION OF THE HF CABLE. BASED ON THE EVALUATION RESULTS, THE MOST PROBABLY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO OPERATOR ERROR AS THE INSTRUCTION MANUAL PROVIDES A WARNING STATEMENT THAT A BRITTLE OR DEFECTIVE INSULATION CAN CONTRIBUTE TO HF CABLE DAMAGE. ADDITIONAL NOTE: THE OEM PERFORMED THE MANUFACTURING AND QUALITY REVIEW FOR THE DEVICE AND AFFECTED LOT NUMBER AND REVEALED NO DEVIATIONS REGARDING THE FUNCTION AND SAFETY OF THE DEVICE. THE DHR REVIEW REVEALED NO ABNORMALITIES/NON-CONFORMITIES FOR THIS DEVICE. THE ROOT CAUSE OF THE REPORTED DEVICE COMPLAINT HAS YET TO BE DETERMINED AND AN INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, 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.¿ IF THE 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 DURING THE MIDDLE OF A THERAPEUTIC HYSTERO ABLATION PROCEDURE, THE PHYSICIAN WAS PERFORMING A RESECTION USING MONOPOLAR ENERGY WHEN A POP AND A SPARK WAS OBSERVED AT THE WORKING END OF THE REPORTED DEVICE. AS A RESULT, THE SPARK BURNED THE FIRST LAYER OF THE RESIDENT¿S GLOVE. NO USER OR PATIENT INJURY WAS REPORTED. THE NON-OLYMPUS ESU WAS SET AT COAG 100/CUT 100. NO ERROR MESSAGES OR ALERTS WERE OBSERVED ON THE ESU PRIOR TO THE INCIDENT. THE DEVICE WAS RECONNECTED AND THE INTENDED PROCEDURE WAS COMPLETED. ADDITIONALLY, THE USER FACILITY REPORTED THAT THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO ANOMALIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78432 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, HF-CABLE, MONOPOLAR GCJ OLYMPUS WINTER & IBE GMBH A0393 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1