BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMT G-J TUBE

    MDR report key: 3264408 · Received July 31, 2013

    Report

    Report Number
    1526012-2013-00007
    Event Type
    Other
    Date Received
    July 31, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 30, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K123716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE PERFORATION IS BELIEVED TO HAVE BEEN CAUSED BY THE GUIDEWIRE OR ENDOSCOPE BEING USED, AND NOT THE SOFT FLEXIBLE TIP OF THE GJ DEVICE. THE GUIDEWIRE REPORTEDLY USED WITH THE DEVICE WAS NOT MANUFACTURED OR SUPPLIED BY AMT. 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 SILICONE RUBBER, WHICH WOULD NOT CAUSE A JEJUNAL PERFORATION BY ITSELF IF CORRECTLY PLACED. 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. MEDWATCH FORM COMPLETED BY: (B)(6), QA/ REGULATORY SUPERVISOR AND BIOMEDICAL ENGINEER.

    Description of Event or Problem · 1

    EVENT DESCRIPTION: OPERATION WAS BEING PERFORMED TO CONVERT PATIENT FROM A G-TUBE TO A GJ-TUBE. PROCEDURE WAS PERFORMED IN IR. INITIAL G-TUBE PLACEMENT HAD BEEN PERFORMED IN SURGERY. AFTER PROCEDURE WAS COMPLETED, THE PATIENT WAS FOUND TO HAVE A JEJUNAL PERFORATION. PATIENT RETURNED TO SURGERY FOR PERFORATION REPAIR. WHAT WAS THE ORIGINAL INTENDED PROCEDURE. CONVERSION OF A GASTROSTY BUTTON TO A GASTROSTOMY/ JEJUNAL BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357164 AMT G-J TUBE TUBES, GASTROINTESTINAL ( AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. GJ-1410-15 13010172

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other