BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMT G-J TUBE

    MDR report key: 3242689 · Received July 17, 2013

    Report

    Report Number
    1526012-2013-00006
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    February 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. BASED ON A REVIEW OF THE INFORMATION, IT IS NOT BELIEVED THAT THE DEVICE CAUSED THE JEJUNAL PERFORATION. DEPENDING ON THE INSERTION METHOD USED TO PLACE THE DEVICE, THE PERFORATION COULD HAVE BEEN CAUSED BY A GUIDEWIRE OR ENDOSCOPE. IT IS NOT BELIEVED THAT THE DEVICE MALFUNCTIONED. IT IS LIKELY THAT THE PERFORATION WAS CAUSED DURING THE PLACEMENT OF THE DEVICE, AND NOT BY THE DEVICE ITSELF. THE TUBING OF THE DEVICE IS MADE OF A SOFT RUBBER, WHICH WOULD NOT CAUSE A JEJUNAL PERFORATION BY ITSELF IF CORRECTLY PLACED. PLEASE NOTE THAT THIS IS THE FIRST CASE OF THIS FAILURE TYPE THAT HAS BEEN BROUGHT TO OUR ATTENTION. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES. NOR WAS THE DEVICE RETURNED TO AMT FOR ANALYSIS. AMT IS IN CONTACT WITH THE SENDER IN HOPES TO RETRIEVE ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. WE WILL PROVIDE ADDITIONAL INFORMATION TO THE FDA IF THE DEVICE OR ADDITIONAL INFORMATION IS ABLE TO BE OBTAINED AND ITS ANALYSIS CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    PLEASE REFER USER FACILITY REPORT # 5233000000-2013-8004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332905 AMT G-J TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. 13020603

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Other CARDIAC DRUGS