BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 200 E/A

    MDR report key: 2455453 · Received February 13, 2012

    Report

    Report Number
    9610614-2012-00002
    Event Type
    Injury
    Date Received
    February 13, 2012
    Date of Event
    January 5, 2012
    Report Date
    February 13, 2012
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. 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. FINALLY, 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 EVENT. THE INCIDENT DESCRIPTION OF HIGH OUTPUT AND NO OSCILLATING AUDIO TONES INDICATES THAT THE ESU MAY HAVE BEEN IN THE DESIRED ENDOCUT MODE. HOWEVER, NO CONCLUSIVE DETERMINATION AS TO THE CAUSE OF THE INCIDENT COULD BE MADE. NEVERTHELESS, THE ACCOUNT WILL BE INSTRUCTED TO ENSURE THAT THE DESIRED SETTINGS (INCLUDING THE MODE) ARE SELECTED AND THAT ALL SETTINGS ARE CONFIRMED PRIOR TO ACTIVATION. THE INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING OFFERED TO THE INVOLVED STAFF AT THE HOSPITAL. 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 AN ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS USED IN COLONOSCOPY. THE ACCOUNT REPORTED THAT DURING THE POLYPECTOMY, THE OUTPUT WAS TOO HIGH AND THE USUAL AUDIO TONES WERE NOT PRESENT. THE REPORTED MODE USED WAS ENDOCUT. THE PT HAD SOME POST PROCEDURAL BLEEDING. LATER ON, THE PT RETURNED TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL WITH A PERFORATION. NO FURTHER PT INFO WAS PROVIDED.

    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 67 YR Required Intervention