BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFMED

    MDR report key: 1751257 · Received June 22, 2010

    Report

    Report Number
    8020045-2010-00010
    Event Type
    Injury
    Date Received
    June 22, 2010
    Report Date
    June 21, 2010
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    GEI
    PMA / PMN Number
    K030362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED ELECTRICALLY, THERMALLY AND MECHANICALLY. ALL SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE PHOTO OF THE INJURY IS NOT UNAMBIGUOUS. IT SHOWS DISCOLORATIONS AROUND THE INJURY WHICH DO NOT CORRESPOND WITH THE SIZE AND GEOMETRY OF THE ELECTRODE. THEY RATHER SEEM TO CORRESPOND WITH A WOUND CARE TAPE. THE YELLOWISH DISCOLORATION SURROUNDING THAT SHAPE INDICATE THE USE OF A DISINFECTANT OR A DIFFERENT ADHESIVE. IF IT CORRESPONDED WITH A WOUND CARE PRODUCT APPLIED AFTER THE BURN, IT IS NOT CLEAR WHY A DISINFECTANT WAS APPLIED ON TOP OF IT. THE SIZE AND SHAPE OF THE BURN IS NOT TYPICAL FOR AN ESU BURN. IT MUCH RATHER CORRESPONDS WITH A BURN CAUSED BY A PREVIOUS INJURY, E.G. AN INJECTION. THE IFU STATES ON ELECTRODE PLACEMENT "AVOID SKIN SITES OVER (...) LESIONS OF ANY KIND". HOWEVER, NO FURTHER CONCLUSION CAN BE DRAWN HERE DUE TO LACK OF INFORMATION PROVIDED. IN ADDITION, THE IFU EXPLICITLY STATES A WARNING "IF AN ELECTROSURGICAL UNIT OFFERS A PLATE MONITORING SYSTEM (LIKE REM, NESSY ETC.), ALWAYS USE A SPLIT PLATE. A PLATE MONITORING SYSTEM CANNOT WORK WITH A STANDARD UN-SPLIT PLATE." THE ERBE VIO 300S OFFERS SUCH A MONITORING SYSTEM. THE HOSPITAL HAS USED A NON-SPLIT ELECTRODE . THE USE OF A SPLIT ELECTRODE (INSTEAD THE NON-SPLIT ELECTRODE ACTUALLY USED) WITH ACTIVATED ELECTRODE CONTACT QUALITY MONITORING SYSTEM WOULD HAVE PREVENTED ANY BURN. WE THEREFORE CONCLUDE THAT A USER ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, WE HAVE BEEN INFORMED ABOUT AN INJURY OF A PATIENT AT (B)(6) UNIVERSITY HOSPITAL, (B)(6). THE DATE OF THE SURGERY AND ITS NATURE ARE STILL UNKNOWN TO US. A NON-MONITORING DISPERSIVE ELECTRODE (MODEL RS08) AND A ELECTROSURGICAL GENERATOR (MODEL ERBE VIO 300S) WERE USED. WE ADDITIONALLY RECEIVED TWO PHOTOS SHOWING THE BURNED THIGH OF THE PATIENT. BECAUSE OF THE CUSTOMER PHOTO, WE ASSUME THAT THE SIZE OF THE BURN IS APPROX. 5X5MM. NO INFORMATION OF THE DEGREE OF THE BURN, ITS RELATIVE LOCATION TO THE ELECTRODE, THE ORIENTATION OF THE ELECTRODE ON THE PATIENT, THE POWER SETTING USED AND HOW THE BURN WAS TREATED AFTERWARDS COULD BE OBTAINED SO FAR DESPITE OF REPEATED REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFMED ELECTROSURGICAL DISPERSIVE ELECTRODE GEI LEONHARD LANG GMBH RS08 SOFT 00308-0806

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other