BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 200 E/A

    MDR report key: 1001944 · Received February 20, 2008

    Report

    Report Number
    9610614-2008-00002
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE GENERATOR SETTINGS WERE CUT MODE: 150 WATTS, ENDO CUT "ON", EFFECT 4 AND COAG MODE: SOFT COAG, 60 WATTS. THE EVAL 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 SPECS AND ALL FEATURES WERE/ARE FUNCTIONING PROPERLY. FURTHERMORE, THERE WAS NO EVIDENCE OF AN INTERNAL SYSTEM PROBLEM WITH THE SETTINGS SINCE OTHER CUSTOMER SETTINGS WERE PRESENT WITHIN THE UNIT. AS A RESULT, IT APPEARS THAT THE ESU WAS SET TO EFFECT 4 (I.E. SAVED IN TEST PROGRAM 1) BY MISTAKE. NONETHELESS, THE GENERATOR WAS RE-SET TO EFFECT 3. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WITH AN ENDO CUT EFFECT 4 SETTING THERE WOULD BE MORE TISSUE COAGULATION (HEMOSTASIS) AS COMPARED TO A SETTING OF EFFECT 3. HOWEVER, IT IS UNK AT THIS TIME WHAT SETTING WAS USED AND IF A SETTING DIFFERENCE COULD HAVE CAUSED OR BEEN ASSOCIATED WITH THE EVENT (NOTE: AS REPORTED THERE WAS ALSO EXCESSIVE DISSENTION OF THE BOWEL DUE TO INSUFFLATION). NONETHELESS, THE ACCOUNT WILL BE ADVISED TO ENSURE THAT DESIRED SETTINGS ARE CONFIRMED PRIOR TO ACTIVATION. THE CUSTOMER IS BEING NOTIFIED OF OUR FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL INSERVICE WORK IS BEING PLANNED AT THE HOSP. 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 USED IN A POLYPECTOMY PROCEDURE. WHILE USING THE ESU AND A SNARE WIRE, A POSSIBLE BURN OR BOWEL PERFORATION OCCURRED. THEREFORE, THE ESU WAS EVALUATED BY THE HOSPITAL'S BIOMEDICAL/CLINICAL ENGINEERING DEPT. THEY FOUND THAT THE GENERATOR WAS WITHIN SPECS, BUT THE UNIT'S DEFAULT ENDO CUT SETTING WAS EFFECT 4 INSTEAD OF EFFECT 3. THE ACCOUNT FURTHER REPORTED THAT DURING THE PROCEDURE THERE WAS EXCESSIVE DISSENTION OF THE BOWEL DUE TO INSUFFLATION WHICH WAS NOT RELATED TO THE GENERATOR. THE PT HAS SINCE BEEN RELEASED AND NO OTHER CLINICAL ISSUES HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R