BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEGADYNE

    MDR report key: 3022654 · Received March 21, 2013

    Report

    Report Number
    8020045-2013-00002
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 21, 2013
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K063161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 2 RETAINED SAMPLES. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE DEVICES INVOLVED IN THE INCIDENT WERE IN A STATE NOT SUITABLE FOR TESTING. WE KEEP INQUIRING FOR MORE INFORMATION AND WILL RELAY ANY FURTHER INFORMATION OR CONCLUSION IN A FOLLOW UP REPORT, IF WE RECEIVE ADDITIONAL INFORMATION. OTHERWISE WE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A 50 MINUTES RADIOFREQUENCY ABLATION (RFA) OF THE LIVER WAS PERFORMED AT (B)(6) HOSPITAL. A BSC RF 3000 RADIOFREQUENCY GENERATOR AND 4 PREWIRED DISPERSIVE ELECTRODES (MODEL RS01B30) WERE USED. THE INITIAL REPORT STATED:" (...) FOUR PATIENT RETURN ELECTRODES WERE ATTACHED TO THE PATIENT THIGH (...)". WHEN THE ELECTRODES WERE REMOVED AFTER THE PROCEDURE, SKIN WAS PEELED OFF WITH 2 OF 4 ELECTRODES. IT WAS STATED IN THE INITIAL REPORT:" (...) BECAUSE A PART OF THE SKIN ATTACHED OUTSIDE OF AN ELECTRODE PART WHEN THEY CHECKED THE PATIENT RETURN ELECTRODES, IT WAS THOUGHT THAT THE SKIN OF THE PATIENT WAS WEAK(...)". THE INVOLVED ELECTRODES SHOWED ONE PIECE OF REMOVED SKIN OF 32X20MM AND ANOTHER OF 7X7MM. THE HOSPITAL STATED THAT THE REMOVAL OF SKIN DID NEITHER CAUSE PATIENT COMPLICATIONS NOR PROLONG HIS STAY IN THE HOSPITAL. NO FURTHER DETAILS OF THE PATIENT, SKIN PREPARATION, THE SURGICAL PROCEDURE OR ANY TREATMENT, WHICH MAY HAVE BEEN NECESSITATED BY THE SKIN REMOVAL, HAVE BEEN DISCLOSED SO FAR DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116927 MEGADYNE ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS01B30 20116-0741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other