BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLONOSCOPE

    MDR report key: 3829848 · Received May 19, 2014

    Report

    Report Number
    MW5036188
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FDF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING COLONOSCOPY IN ENDOSCOPY. SOON INTO PROCEDURE, PT RECEIVED A 1.5CM PERFORATION/HOLE IN MID DESCENDING COLON. THE ATTENDING PHYSICIAN IMMEDIATELY CONFIRMED PERFORATION. PT WAS BROUGHT TO EMERGENCY ROOM. PT WAS STABILIZED AND TRANSFERRED TO SURGICAL SERVICES FOR LAP EXPLORATION OF ABDOMEN. PERFORATION WAS SURGICALLY REPAIRED. PT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295364 COLONOSCOPE COLONOSCOPE FDF OLYMPUS AMERICA, INC. PCF-H180AL

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R