BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 20272494 · Received September 20, 2024

    Report

    Report Number
    8020045-2024-00019
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Report Date
    October 3, 2024
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    04050147015524
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER THE 510K REFERENCE: K063161). NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR. WE WILL PROVIDE A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. NO FAULTS WERE DETECTED. THE VISUAL INVESTIGATION OF THE CONCERNED CUSTOMER SAMPLE 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 ONE SIMILAR COMPLAINT RECORDED. THEREFORE IT WAS ASSESSED TO INITIATE A CAPA INTRODUCING FURTHER ACTIONS TO AVOID THE CLAIMED ERROR IN THE FUTURE. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 0

    ON AUGUST 23ST, 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT UNKNOWN USER FACILITY. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY®PLATE 170 ZWEITEILIG (MODEL XL31A) AND AN UNKWNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "THE INSULATION IS MISSING AT THE NESSY CONNECTION. THE CABLE CONNECTIONS ARE EXPOSED!" NO FURTHER DETAILS HAVE BEEN DISCLOSED SO FAR DESPITE FURTHER REQUESTS.

    Description of Event or Problem · 0

    ON AUGUST 23 ST, 2024, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT AN UNKNOWN USER FACILITY. A MONITORING DISPERSIVE ELECTRODE ERBE NESSY®PLATE 170 (MODEL XL31A) AND AN UNKNOWN GENERATOR HAVE BEEN USED. THE INITIAL REPORTER STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "THE INSULATION IS MISSING AT THE NESSY CONNECTION. THE CABLE CONNECTIONS ARE EXPOSED!" WE HAVE RECEIVED A PICTURE SHOWING 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 SO FAR DESPITE FURTHER REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471278 ERBE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH XL31A 231204-2403 04050147015524

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other