BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 2161039 · Received November 3, 2008

    Report

    Report Number
    2161039
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    June 17, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COLONOSCOPY WITH POLYPECTOMY DONE WITH ESU AND COLONOSCOPE. A 1X1.5CM POLYP REMOVED IN PIECEMEAL FASHION. PT ADMITTED TO HOSP NEXT DAY WITH SEVERE RLQ PAIN. DIAGNOSED WITH COLON HEMATOMA THAT SUBSEQUENTLY REQUIRED 8 DAYS OF HOSPITALIZATION. REPORTEDLY, SOME GASTROENTEROLOGISTS FELT THE AMOUNT OF VOLTAGE RELEASED WITH THE ENDOCUT WAS TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE VIO 300 D ESU GENERATOR GEI ERBE USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R