BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8136337 · Received December 5, 2018

    Report

    Report Number
    2951238-2018-00742
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 1, 2018
    Report Date
    May 29, 2019
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCJ
    UDI-DI
    04042761001656
    PMA / PMN Number
    K944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CABLE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. AS PREVENTIVE MEASURES, THE CABLE INSTRUCTIONS STATE, ¿DO NOT USE THE HF CABLE AFTER ONE YEAR OF USE.¿ ¿VISUALLY INSPECT THE CABLE AND THE PLUGS FOR IRREGULARITIES ON THE SURFACE.¿ AND ¿DO NOT USE A CABLE WITH BRITTLE OR DEFECTIVE INSULATION. REPLACE THE CABLE.¿ THE INSTRUCTIONS ALSO WARN, ¿USE ONLY COMPATIBLE EQUIPMENT¿ LISTED IN THE INSTRUCTIONS, AND ¿THE MAXIMUM OUTPUT VOLTAGE OF THE HF UNIT MUST NOT EXCEED THE LOWEST MAXIMUM RATED VOLTAGE OF ANY OF THE HF COMPONENTS USED DURING THE PROCEDURE.¿ A REVIEW OF THE DEVICE DHR ALSO SHOWED NO RELATED MANUFACTURING ANOMALIES AT THE TIME OF PRODUCT RELEASE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULTS. THE DEVICE WAS RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE UNDER A MICROSCOPE AND FOUND TRACES OF BURNT, CHARRING DEPOSIT ON THE INTERNAL WIRINGS AND INSULATION AS SIGNS OF THERMAL DAMAGE. HOWEVER, BASED ON THE INVESTIGATION FINDINGS AND SIMILAR REPORTED EVENTS, THE REPROCESSING, MOISTURE INVASION, OR MECHANICAL STRESS DUE TO CABLE BEING PULLED THAT COULD HAVE DAMAGED THE INTERNAL WIRINGS OF THE HF CABLE; WHEN THE HF CURRENT WAS ACTIVATED, THE INTERNAL WIRINGS BECAME BURST AND BROKE. IN ADDITION, THE CABLE WAS MANUFACTURED IN 2009, CABLE SHOULD BE DISPOSED OF AFTER 12 MONTHS OF USE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT AT THE BEGINNING OF A TRANSURETHRAL RESECTION OF BLADDER TUMOR, THE PHYSICIAN SMELLED SMOKE AND DISCOVERED THAT THE CORD DEVICE CONNECTING THE HANDPIECE AND GENERATOR WAS SPARKING AND SMOKING AT THE GENERATOR END. A BREAK WAS SEEN IN THE OUTER SHEATH NEAR THE STRAIN RELIEF ON THE PLUG. THE CORD WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NEW CORD. THERE WAS NO REPORTED INJURY TO EITHER PATIENT OR CLINICIAN. IT WAS REPORTED THAT THE MALFUNCTIONING CORD HAD BEEN IN SERVICE FOR OVER A YEAR, AND THAT IT HAD BEEN INSPECTED PRIOR TO USE WITH NO ANOMALIES FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976043 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40 ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE GCJ OLYMPUS WINTER & IBE GMBH A0393 049644 04042761001656

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR ESU BOVIE GENERATOR| UNKNOWN MODEL HANDPIECE