BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 4080887 · Received September 4, 2014

    Report

    Report Number
    MW5038135
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 4, 2014
    Manufacturer
    OLYMPUS
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPE VIDEO CABLE TO THE TOWER MONITOR MALFUNCTIONED AND STOPPED SHOWING A PICTURE FOR THE TEAM TO CONTINUE WITH PEG PROCEDURE. NO ISSUE WITH SCOPE, JUST THE SCREEN CABLES. WIRE WAS JUST ABOUT TO BE PASSED THROUGH THE TROCAR (11 BLADE SCALPEL) AND ABOUT TO GRAB SNARE WHEN THE IMAGE WAS SHUT OFF AND NOT ABLE TO RELIABLY GET THE IMAGE BACK. PROCEDURE WAS ABORTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539677 OLYMPUS ENDOSCOPE VIDEO CABLE KOG OLYMPUS OEV191H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization