BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 16500814 · Received March 8, 2023

    Report

    Report Number
    8020045-2023-00004
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    04050147015524
    PMA / PMN Number
    K030362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE PREWIRED DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER K030362). RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. NO FAULTS WERE DETECTED. THE CONCERNED DEVICE WAS DISINFECTED BEFORE INVESTIGATION. THE VISUAL INVESTIGATION HAS SHOWN THAT THE FOAM INSULATION OF THE CABLE RIVETING WAS MISSING. WE ASSUME THAT THE FAILURE WAS CAUSED BY AN ASSEMBLY EMPLOYEE. DURING THE SUBSEQUENT MANUAL PACKAGING OF THE ASSEMBLED NEUTRAL ELECTRODES IT WAS NOT DISCOVERED THAT THE FOAM INSULATION WAS MISSING. THE IFU CONTAINS A MITIGATING WARNING: "THIS PRODUCT MAY BE USED ONLY BY TRAINED MEDICAL STAFF, WHO HAVE BEEN SHOWN HOW TO USE IT ACCORDING TO THE INSTRUCTIONS FOR USE. CHECK THE PRODUCT BEFORE USE FOR EXTERNAL DAMAGE! NEVER USE DAMAGED RETURN ELECTRODES, CABLES OR PLUGS." WE HAVE REVIEWED OUR COMPLAINT DATABASE. DURING THE LAST 5 YEARS WE HAVE PRODUCTED MORE THAN 20 MILLION PCS OF PREWIRED DISPERSIVE ELECTRODES AND NO SIMILAR COMPLAINT WAS RECORDED. THE INCIDENT WAS THEREFORE ASSESSED TO BE A SINGLE ERROR AND NO FURTHER ACTIONS WILL BE CARRIED OUT SO FAR. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN TO ENGLISH]: "THE COVER THAT SHOULD BE ON THE CONNECTOR IS MISSING. IT IS A COMPLAINT FROM AN END USER." ON (B)(6) 2023 WE HAVE RECEIVED THE CONCERNED CUSTOMER SAMPLE SHOWING THAT THE RIVET INSULATION ON THE NEUTRAL ELECTRODE NECK OF THE ATTACHED CABLE IS MISSING. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164024 ERBE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH XL31A 220617-2403 04050147015524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other