BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUJET

    MDR report key: 2942177 · Received January 30, 2013

    Report

    Report Number
    2942177
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    April 4, 2013
    Report Date
    January 30, 2013
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE WAS TAKEN OUT OF THE PACKAGE, UNRAVELED, AND HANDED TO THE DOCTOR. NO ADJUSTMENT TO NEEDLE AT ALL. DOCTOR ORDERED NEEDLE OUT TO PRIMER INSIDE OF PATIENT. NEEDLE DID NOT COME OUT. THE DOCTOR TRIED AGAIN. NEEDLE WAS FOUND COMING OUT THE SIDE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ESOPHAGOGASTRODUODENOSCOPY (EGD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40590 ACUJET NEEDLE FCG COOK ENDOSCOPY * W3211484

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR EGD SCOPE| NO OTHER THERAPIES