BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE

    MDR report key: 1913102 · Received July 28, 2010

    Report

    Report Number
    1913102
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ERBE
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A DIAGNOSTIC COLONOSCOPY WITH 4 POLYPECTOMIES ON (B)(6) 2010. DURING FIRST 2 POLYPECTOMIES, PROVIDER EXPRESSED CONCERN THAT ERBE WAS CUTTING TOO QUICKLY AND DID NOT SEEM TO BE COAGULATING. MACHINE WAS TAKEN OUT OF SERVICE AND SECOND MACHINE PROVIDED FOR USE. PT DISCHARGED HOME SAME DAY. PT PRESENTED TO ED ON (B)(6) 2010 WITH PERFORATION OF COLON -SURGICAL INTERVENTION IN OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE ES UNIT/CAUTERY UNIT GEI ERBE ICC-200-E-UL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R