BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 200 E

    MDR report key: 2655778 · Received July 6, 2012

    Report

    Report Number
    9610614-2012-00008
    Event Type
    Other
    Date Received
    July 6, 2012
    Date of Event
    May 31, 2012
    Report Date
    July 6, 2012
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY EVALUATED. THE GENERATOR WAS FOUND TO BE FUNCTIONING AS INTENDED. SPECIFICALLY, A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON THE ESU. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS PERFORMED WITH THE INVOLVED MEDICAL PERSONNEL ON 06/29/2012. ADDITIONALLY, THE ACCOUNT WILL BE ADVISED TO CHOOSE AND ADJUST SETTINGS AS NECESSARY TO OBTAIN THE DESIRED TISSUE EFFECT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. 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 PT INCIDENT. THE ESU WAS BEING USED TO REMOVE A POLYP. THE SETTINGS WERE CUT 200 WATTS/SOFT COAG 60 WATTS, EFFECT 3. THE SNARE ADHERED TO THE POLYP TISSUE AND THEY WERE UNABLE TO REMOVE IT. THEREFORE, THE SURGERY WAS PERFORMED TO REMOVE THE SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBOTOM ICC 200 E ELECTROSURGICAL GENERATOR GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention