BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 15713336 · Received November 2, 2022

    Report

    Report Number
    8020045-2022-00029
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Report Date
    December 15, 2022
    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

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. NO FAULTS WERE DETECTED. THE INVOLVED DEVICE HAS NOT BEEN MADE AVAILABLE TO US YET. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE PREWIRED DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER K030362). WE HAVE REQUESTED THE CONCERNED PRODUCT FOR FURTHER INVESTIGATION. WE WILL RELAY ANY CONCLUSION IN A FOLLOW UP REPORT.

    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 NOVEMBER 29TH, 2022, WE HAVE BEEN INFORMED BY THE CUSTOMER THAT THE CONCERNED DEVICE WAS AVAILABLE FOR INVESTIGATION AND WOULD BE RETURNED TO LEONHARD LANG GMBH. IT WAS RECEIVED ON DECEMBER 07TH, 2022. THE CONCERNED DEVICE WAS DISINFECTED BEFORE INVESTIGATION. THE VISUAL INVESTIGATION HAS SHOWN THAT ONLY ONE SIDE OF THE ALUMINUM WAS CONNECTED TO THE RING TERMINAL OF THE CABLE. ON THE OTHER SIDE OF THE SPLIT ELECTRODE ALUMINUM A RIVET WAS PRESENT BUT NO RING TERMINAL OF THE CABLE. THE RIVETING POINTS ARE INSULATED WITH ADHESIVE FOAM TO PROTECT PATIENT AND USER. THE RING TERMINAL OF THE CABLE WAS ONLY LOOSELY HELD IN PLACE BY THE ADHESIVE FOAM INSULATION. THIS APPARENTLY LED TO ONLY ONE HALF OF THE ELECTRODE BEING CONTACTED BY BOTH CABLES AND THE ELECTRODE MONITORING SYSTEM THUS SHORTED OUT. THIS COULD HAVE LED TO A PATIENT BURN. DURING THE RIVETING PROCESS, THE ELECTRODE IS INSERTED INTO THE RIVETING MACHINE. THE RING TERMINALS OF THE CABLE ARE PUT ON TWO PINS SO THAT THE RIVETING TAKES PLACE IN THE CORRECT POSITION. WE ASSUME THAT ONE RING TERMINAL OF THE CABLE SLIPPED OUT OF THE HOLD-DOWN BRACKET DURING THE RIVETING PROCESS BUT STAYED CLOSE TO ITS INTENDED POSITION DUE TO THE STIFFNESS OF THE CABLE. 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 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) 2022, 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 LANGUAGE TO ENGLISH LANGUAGE]: "THE CRIMP CONTACTS (RING EYELET) WERE BOTH INSERTED ON JUST ONE CONTACT SURFACE OF THE NESSY [ELECTRODE CONNECTING TA], WHICH MEANT THAT THE RESISTANCE VALUE WAS TOO LOW AND THE NESSY [ELECTRODE CONNECTING TA] COULD NOT BE USED. NORMALLY THERE SHOULD BE ONE CRIMP CONTACT PER ELECTRODE SIDE."

    Description of Event or Problem · 0

    ON OCTOBER 12TH, 2022, 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 CRIMP CONTACTS (RING EYELET) WERE BOTH INSERTED ON JUST ONE CONTACT SURFACE OF THE NESSY [ELECTRODE CONNECTING TAB], WHICH MEANT THAT THE RESISTANCE VALUE WAS TOO LOW AND THE NESSY [ELECTRODE CONNECTING TAB] COULD NOT BE USED. NORMALLY THERE SHOULD BE ONE CRIMP CONTACT PER ELECTRODE SIDE." NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2914040 ERBE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH XL31A 220617-2403 04050147015524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other