BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 200 E

    MDR report key: 1847272 · Received September 24, 2010

    Report

    Report Number
    9610614-2010-00019
    Event Type
    Other
    Date Received
    September 24, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 INVOLVED MEDICAL PERSONNEL ARE BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WILL BE OFFERED TO BE PERFORMED AT THE MEDICAL CENTER WITH THE INVOLVED STAFF. 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 A COLONOSCOPY. HOT BIOPSY FORCEPS AND A LOOP ELECTRODE WERE USED TO REMOVE A POLYP. A BOWEL BURN AND BLEEDING OCCURRED AT THE OPERATIVE SITE (NOTE: PHYSICIAN IS QUESTIONING IF UNIT'S OUTPUT OR EFFECT WAS TOO GREAT). AT THIS TIME IT IS UNKNOWN IF ANY SURGICAL INTERVENTION WAS/IS REQUIRED.

    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 74 YR