BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 200

    MDR report key: 3120096 · Received May 14, 2013

    Report

    Report Number
    3120096
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS CONCERNED WITH HOW FAST THE CAUTERY CUT AND QUESTIONED THE NURSE AS TO THE HEAT SETTINGS ON THE ERBE UNIT. THEY WERE CONFIRMED AS CORRECT. THERE WAS CONCERN THAT THE ERBE MACHINE PRODUCED EXCESSIVE HEAT TOO RAPIDLY AND THIS MAY HAVE RESULTED IN THE COLON PERFORATION THAT REQUIRED ADMISSION TO THE HOSPITAL (THE NEXT DAY) RESULTING IN BOWEL RESECTION SURGERY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COMPLETE COLONOSCOPY WITH HOT SNARE POLYPECTOMY AND COMPLETE COLONOSCOPY WITH BIOPSY OF SESSILE TRANSVERSE COLON POLYP, UNRESECTABLE AND INJECTION OF SPOT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212591 ERBE ICC 200 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ERBE USA, INC. * *
    212592 CAPTIFLEX MEDIUM OVAL - FLEXIBLE SINGLE USE SNARE SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R SNARE