BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJINON SINGLE-USE DOUBLE BALLOON OVERTUBE

    MDR report key: 1729471 · Received June 16, 2010

    Report

    Report Number
    MW5016391
    Event Type
    Malfunction
    Date Received
    June 16, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 3, 2010
    Manufacturer
    FUJINON, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING DOUBLE BALLOON ENDOSCOPY, ANTEGRADE APPROACH, WITH A FUJINON DOUBLE-BALLOON ENTEROSCOPE SYSTEM. THE OVERTUBE BALLOON FAILED TO COMPLETELY COLLAPSE AND WAS REMOVED FROM THE PT WHILE REMAINING INFLATED DURING INSTRUMENT WITHDRAWAL FROM THE PT. THE BALLOON-PUMP CONTROLLER FAILED TO DETECT (OR SOUND ALARM) THAT THE OVERTUBE BALLOON WAS STILL INFLATED WHILE THE INSTRUMENT WAS BEING WITHDRAWN. NO SERIOUS PT COMPLICATIONS NOTED. MANUFACTURER HAS BEEN CONTACTED. OTHER INFO: MANUFACTURER MONTH: 03/2010. STERILIZATION # (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUJINON SINGLE-USE DOUBLE BALLOON OVERTUBE ENDOSCOPY OVERTUBE GCJ FUJINON, INC. TS-13140 100218

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR