BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBETOM ICC 200 E

    MDR report key: 1439440 · Received August 11, 2009

    Report

    Report Number
    9610614-2009-00013
    Event Type
    Other
    Date Received
    August 11, 2009
    Date of Event
    July 17, 2009
    Report Date
    August 11, 2009
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS EVALUATED BY THE HOSP'S BIOMEDICAL DEPT. IT WAS FOUND TO BE FUNCTIONING AS INTENDED. THEREFORE, THE GENERATOR WAS PUT BACK INTO SERVICE BY THE FACILITY (NOTE: THE CUSTOMER DID NOT BELIEVE IT WAS NECESSARY TO HAVE THE UNIT CHECKED BY ERBE. THE GENERATOR HAS SINCE BEEN PLACED BACK INTO SERVICE WITHOUT ANY ISSUES.) NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF ANY OF THE ACCOUNT'S ESUS MODEL ICC 200 E. A REVIEW OF THE INCIDENT REVEALED THAT THE PT HAD A LARGE STALKED POLYP WHICH WAS WELL VASCULARIZED. ALSO, IT APPEARS THAT THE POLYP MAY HAVE BEEN COLD SNARED BECAUSE THE GENERATOR'S NEUTRAL ELECTRODE SAFETY SYSTEM (NESSY) HAD NOT BEEN SATISFIED [NOTE: THE UNIT'S NESSY LIGHT EMITTING DIODE (LED) WAS NOT "GREEN" BECAUSE THE RETURN ELECTRODE WAS NOT SECURE ON THE PT; THEREFORE, NO OUTPUT WAS DELIVERED FROM THE UNIT.]. AS A RESULT, THE PT'S CONDITION (I.E HAVING A LARGE VASCULARIZED POLYP) IN COMBINATION WITH NO CAUTERY BEING APPLIED APPEARS TO HAVE LED TO THE BLEEDING THAT WAS ENCOUNTERED. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. TO FURTHER ADDRESS THE ISSUE, THE CUSTOMER WILL BE ADVISED TO ENSURE THAT THE UNIT'S SAFETY SYSTEM IS SATISFIED PRIOR TO ACTIVATION (NOTE: THE ACCOUNT DOES NOT FEEL THAT ADDITIONAL IN-SERVICE TRAINING IS NECESSARY AT THIS TIME.). 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 DURING A POLYPECTOMY. THE SETTINGS WERE FORCED COAG, 24 WATTS AND ENDOCUT MODE, 200 WATTS AT EFFECT 3. UPON REMOVING A VERY LARGE STALKED POLYP, EXCESSIVE BLEEDING OCCURRED. THE CUSTOMER STATED THAT NO THERMAL/TISSUE EFFECT WAS OBSERVED (I.E NO CAUTERY WAS DELIVERED) BECAUSE THE NEUTRAL ELECTRODE SAFETY SYSTEM (NESSY) HAD NOT BEEN SATISFIED. THE PT WAS SENT TO THE ICU DUE TO THE LOSS OF BLOOD BUT SINCE HAS RECOVERED AND BEEN RELEASED. NO PT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization