BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 200 E/A

    MDR report key: 2833083 · Received November 6, 2012

    Report

    Report Number
    9610614-2012-00017
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND 8 POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENTS. MOST LIKELY THERE WERE MANY FACTORS INVOLVED WITH THE PT INCIDENTS (E.G. THE DISEASE STATE, AGE OF THE PTS, ETC). IT APPEARS THAT UPON THE INTERVENTION WORK IN THE COLON ON BOTH PTS, THE REMAINING WALL WAS NOT SUFFICIENT REMAIN INTACT. NONETHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENTS. NO TRENDS HAVE BEEN IDENTIFIED WITH THESE INCIDENTS. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (2) PT INCIDENTS OCCURRED ((B)(6) 2012 RESPECTIVELY) DURING COLONOSCOPIES WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). NO PT OR EQUIPMENT SETTING INFO WAS PROVIDED. IN EACH CASE UPON THE INTERVENTION WORK A DELAYED BOWEL WALL PERFORATION OCCURRED. NO FURTHER INFO WAS PROVIDED INVOLVING HOW THE PERFORATIONS WERE MEDICALLY TREATED. NOTE: THE ESU IS SIMILAR TO A MODEL DISTRIBUTED IN THE U.S. IT WAS DISTRIBUTED TO A HOSPITAL IN (B)(6).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other