BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II COLONOVIDEOSCOPE

    MDR report key: 4173493 · Received October 10, 2014

    Report

    Report Number
    2951238-2014-00399
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 24, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    NWB
    PMA / PMN Number
    K100584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY AT THE END OF THE PROCEDURE WHEN THE PHYSICIAN WAS EXTRACTING THE SCOPE, THE TIP OF THE DEVICE BROKE OFF AND WAS STUCK INSIDE THE PATIENT. THE PHYSICIAN BELIEVES IT GOT STUCK ON A GROWTH NEXT TO THER HERNIA AND BROKE. THERE WAS NO EXCESSIVE BLEEDING OR ANY SERIOUS INJURY TO THE PATIENT DURING THAT TIME. THE PATIENT WAS TRANSPORTED VIA AMBULANCE TO THE HOSPITAL WHERE THE TIP WAS SUCCESSFULLY RETRIEVED USING X-RAY GUIDANCE. THE PATIENT WAS DISCHARGED IN GOOD CONDITION THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642760 EVIS EXERA II COLONOVIDEOSCOPE COLONOVIDEOSCOPE NWB OLYMPUS MEDICAL SYSTEMS CORPORATION CF-H180AL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R