BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 21394991 · Received February 18, 2025

    Report

    Report Number
    8020045-2025-00003
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Report Date
    February 18, 2025
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    04050147005167
    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. ON FEBRUARY 12TH, 2025, WE HAVE RECEIVED THE CONCERNED DEVICE FOR FURTHER INVESTIGATION. THE VISUAL INVESTIGATION HAS SHOWN THAT ONE SIDE OF THE CONDUCTIVE ALUMINUM WAS BENT IN THE AREA OF THE CONNECTING TAB AND THEREFORE BOTH CONDUCTIVE ALUMINIUM AREAS HAVE BEEN RIVETED AT ONE SIDE TO THE RING TERMINAL OF THE CABLE. ON THE OTHER SIDE OF THE SPLIT ELECTRODE THE BENT ALUMINUM WAS ALSO TOUCHING THE SECOND RIVET OF THE CABLE RING TERMINAL. A CONNECTION OF BOTH CONDUCTIVE ALUMINUM RESULTED, EFFECTIVELY SHORTING THEM OUT.. THE CONNECTION OF BOTH CONDUCTIVE ALUMINUM SIDES HAVE CAUSED THE GENERATOR TO RECOGNIZE THE SPLIT MONITORING DISPERSIVE ELECTRODE AS AN UNSPLIT NONMONITORING ELECTRODE. WE ASSUME THAT A DEFECTIVE DISPERSIVE ELECTRODE, WHICH WAS NOT SORTED OUT IN THE MANUFACTURING PROCESS, WAS RIVETED. DURING THE SUBSEQUENT MANUAL ASSEMBLY OF THE FOAM INSULATION IT WAS NOT DISCOVERED THAT ONE END OF THE CABLE WAS NOT CORRECTLY FIXED TO THE ELECTRODE. WE CONSIDER THIS A FREAK ESCAPE. WE CONCLUDE A MANUFACTURING PROBLEM LED TO THE INCIDENT. WE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON JANUARY 30TH, 2025 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A MONITORING 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 LANGUAGE]: "CUSTOMERS NOTICED: NE [MONITORING DISPERSIVE ELECTRODE] IS IN TWO PARTS, BUT IS RECOGNIZED BY THE DEVICE AS ONE PART. CAN BE REPRODUCED ON HF DEVICE [GENERATOR]. (...) INSULATION AROUND ELECTRODE CONNECTING TAB REMOVED FOR ANALYSIS PURPOSES. CONACTING TAB OF ONE SIDE OF THE CONDUCTIVE [ALUMINUM] MATERIAL IS BENT IN CONTACT SURFACE [ELECTRODE CONNECTING TAB] AND IS ALSO CONNECTED TO THE OTHER SIDE OF THE CONDUCTIVE [ALUMINUM] MATERIAL BY A CRIMP CONTACT. (SHORT CIRCUIT)". NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623951 ERBE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH XL31A 240724-2401 04050147005167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other