BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 200 E

    MDR report key: 769305 · Received October 10, 2006

    Report

    Report Number
    9610614-2006-00019
    Event Type
    Other
    Date Received
    October 10, 2006
    Report Date
    October 6, 2006
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU AND ACCESSORIES (E.G., NON-ERBE ACTIVE CORD AND FOOTSWITCH) WERE RETURNED AND EVALUATED. THE GENERATOR, NON-ERBE ACTIVE CORD, AND FOOTSWITCH WERE FOUND TO BE WORKING AS INTENDED. HOWEVER, THE ENDO CUT MODE DEFAULT SETTING WAS FOUND TO BE "OFF." NONETHELESS, A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT TO CONFIRM THAT ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. NO FAILURES/DEFECTS WERE FOUND WITH THE ESU THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT (NOTE: NO ADJUSTMENTS WERE MADE TO THE UNIT. HOWEVER, A COVER SHEET AS TO THE STATUS OF THE ESU HAVING THE ENDO CUT MODE DEFAULT BEING "OFF" WAS PLACED ON THE GENERATOR. THE CUSTOMER IS NOT TO USE THE UNIT UNTIL ADDITIONAL INSERVICING TAKES PLACE AT THEIR FACILITY BY AN ERBE REPRESENTATIVE.). NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) FOR THE GENERATOR. THE SETTINGS USED IN THE PROCEDURE WERE NOT REPORTED TO US. HOWEVER, IF THE ENDO CUT MODE WAS DESIRED AND NOT ENGAGED; A HOTTER/FASTER CUT AS REPORTED WOULD BE DELIVERED. NEVERTHELESS, NO CONCLUSIVE DETERMINATION AS TO THE CAUSE OF THIS SITUATION COULD BE MADE. A RESPONSE LETTER FOR THE ACCOUNT IS BEING PROVIDED AND OUR REPRESENTATIVE IS TO PERFORM ADDITIONAL TRAINING AT THE MEDICAL CENTER AND IF DIRECTED BY THE CUSTOMER RE-INITIALIZE THE ENDO CUT MODE AS THE DEFAULT. 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

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT'S (ESU'S/GENERATOR'S) OUTPUT WAS HOTTER OR THE UNIT CUT FASTER THAN EXPECTED DURING A POLYPECTOMY. A PERFORATION OCCURRED. AT THE TIME OF THE REPORTED EVENT NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION OR PATIENT DATA WAS PROVIDED.

    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 NO INFO Other