BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLS MARTIN

    MDR report key: 10850350 · Received November 17, 2020

    Report

    Report Number
    8020045-2020-00026
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    November 17, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    UDI-DI
    04057605234718
    PMA / PMN Number
    NONE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER, NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED SO FAR. AFTER SEVERAL REQUESTS TO OBTAIN ADDITIONAL INFORMATION NONE COULD BE OBTAINED. WE ARE REPORTING THIS INCIDENT BECAUSE WE DISTRIBUTE DISPERSIVE ELECTRODES OF COMPARABLE DESIGN IN THE US (UNDER 510(K) K063161). REVIEWING THE COMPLAINT DATABASE IN THE LAST 3 YEARS WE HAVE HAD NO SIMILAR COMPLAINT ABOUT GEL DELAMINATION DURING THIS TIME. WE THEREFORE, CONCLUDE THAT THIS FAILURE IS A SINGULAR ERROR. BASED ON THE INFORMATION RECEIVED NO ROOT CAUSE ANALYSIS COULD BE PERFORMED. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 1

    ON OCTOBER 13TH, 2020, WE WERE INFORMED ABOUT A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE. WE RECEIVED THE FEEDBACK FROM OUR SALES REPRESENTATIVE FOR HOLLAND. A MONITORING DISPERSIVE ELECTRODE KLS MARTIN PCS DUOSAFE 80-344-09-04 (OUR MODEL#: RS212), AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORTER STATED THAT THEY HAD TWO TIMES GEL RESIDUES OF THE DISPERSIVE ELECTRODE REMAINING ON THE SILICONIZED TRANSPARENT BACKING MATERIAL, AND ON THE PATIENT. WE ALSO HAVE RECEIVED A PICTURE OF THE INITIAL REPORTER SHOWING THE SILICONIZED TRANSPARENT BACKING MATERIAL WITH SOME SMALL GEL RESIDUES AT THE OUTER EDGES OF THE GEL REMAINING ON THE SILICONIZED TRANSPARENT BACKING MATERIAL. NO PATIENT INJURY WAS REPORTED ACCORDING TO THIS MALFUNCTION. WE HAVE REQUESTED FURTHER INFORMATION ON THE CONCERNED LOT NUMBER, DETAILS ON THE PROCEDURE, AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315927 KLS MARTIN ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS212 UNKOWN 04057605234718

    Patients

    Seq Age Sex Outcome Treatment
    1 Other