BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 10709973 · Received October 21, 2020

    Report

    Report Number
    8020045-2020-00024
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Report Date
    October 21, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    04050147015524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. NO FAULTS WERE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE PREWIRED DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER K063161). REVIEWING THE SOLD AMOUNT OF DISPERSIVE ELECTRODES WE HAVE MARKETED 12,4 MILLION PREWIRED DISPERSIVE ELECTRODES IN THE LAST 3 YEARS GLOBALLY (FEBRUARY 01, 2018 TILL TODAY), AND HAVE HAD NO SIMILAR COMPLAINT ABOUT A MISSING CABLE INSULATION DURING THIS TIME. WE THEREFORE, CONCLUDE THAT THIS FAILURE IS A SINGULAR ERROR. NEVERTHELESS, THE IFU ADVISES THE USER TO CHECK THE PRODUCT FOR DAMAGES AND NOT TO USE A DAMAGED PRODUCT. WE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 1

    ON SEPTEMBER 24TH, 2020 WE HAVE BEEN INFORMED ABOUT A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A/1) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORTER STATED THAT UPON OPENING THE PACKAGE IT WAS FOUND THAT THE INSULATION AROUND RIVET AND CABLE TERMINAL WAS MISSING. THIS CAN LEAD TO BURNS DURING THE APPLICATION WITH A VERY HIGH PROBABILITY. NO FURTHER INFORMATION WAS PROVIDED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174116 ERBE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH XL31A/1 180924-2401 04050147015524

    Patients

    Seq Age Sex Outcome Treatment
    1 Other