BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 350

    MDR report key: 5128618 · Received October 5, 2015

    Report

    Report Number
    9610614-2015-00010
    Event Type
    Injury
    Date Received
    October 5, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 5, 2015
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED (NOTE: SOME DISPLAY BUTTONS WERE FOUND TO WORK INTERMITTENTLY, BUT THE ACCOUNT DECLINED FURTHER SERVICING OF THE GENERATOR. THE BUTTONS HAD NO IMPACT ON THE UNIT WORKING PROPERLY.). THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALTERNATE SITE BURNS ARE A TYPICAL COMPLICATION IN ELECTROSURGERY AND THERE ARE MANY POSSIBLE CAUSES (E.G., LEAKAGE CURRENT BEING DISCHARGED THROUGH ELECTRICALLY CONDUCTIVE OBJECTS IN CONTACT WITH THE PATIENT, CAPACITY COUPLING- CURRENT BEING TRANSFERRED TO A NON-ACTIVE INSTRUMENT, ETC.). NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, THE ACCOUNT WILL BE PROVIDED WITH A CURRENT USER MANUAL WHICH INCLUDES SAFETY INSTRUCTIONS THAT HAVE WARNINGS THAT COVER ALTERNATE SITE BURNS. ADDITIONALLY, IN-SERVICE WORK IS BEING PLANNED FOR THE INVOLVED STAFF. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. THE PHYSICIAN EXCISED A TISSUE MASS (POSSIBLY A LIPOMA) FROM THE PATIENT'S BACK. THE SETTINGS WERE HIGH CUT MODE, EFFECT 3, 35 WATTS AND SPRAY COAG MODE, 25 WATTS. AFTER THE INTERVENTION WORK, A SMALL, 1-2 DEGREE SKIN BURN IN THE SHAPE OF A "SEMI-CIRCLE," OR "CRESCENT MOON," ADJACENT TO THE SURGICAL INCISION WAS DISCOVERED. THE BURN WAS VERY CLOSE TO A SKIN RETRACTOR INSTRUMENT BEING USED TO PULL BACK THE SKIN AROUND THE SURGICAL INCISION SITE. NO FURTHER INFORMATION REGARDING THE PATIENT'S STATUS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657495 ERBE ICC 350 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 350

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention