ESOPHYX DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for ESOPHYX DEVICE manufactured by Endogastric Solutions, Inc..

Event Text Entries

[135677585] Dr. (b)(6) performed the tif transoral incisionless fundoplication procedure using the esophyx device. The device esophyx got lodged in my esophagus causing a large hole and tear. The retractors would not retract back in and it tore my esophagus. That caused me to have a metal stent wrapped around my esophagus for a painful 6 weeks. I had reactions to many medications which caused nausea and no appetite. I lost all my muscle mass and could not walk. I was bed ridden for 5 straight months learning to walk again. I went into a depression for the first time in my life. I lost 15 pounds. My diet has changed. I am left with esophageal spasms that constantly never stop. I have weak vocal cords and my voice has changed. I have liquid going down the wrong windpipe causing coughing. I have narrowing of the esophagus that the doctor says he can open as frequently as needed by performing an esophageal scope going into esophagus. That requires anesthesia which is risky. I have discomfort and pain in esophagus daily all day and sleep straight up for over a year. That has led to chronic back pain and disc issues. I had 2 gastroparesis attacks that one was hospitalized. Constipation as well at times. I am worse off than before the surgery to repair a small hiatal hernia. I still now have to take the nexium which my doctor believes after 12 years has caused me to be diagnosed with osteopenia. I had taken a medication in the nitro family that side effects are copd. I now have been diagnosed with copd and have breathing problems and extreme fatigue. I lost my medical billing company of 12 years due to lack of being able to work.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083628
MDR Report Key8297097
Date Received2019-01-31
Date of Report2019-01-30
Date of Event2017-12-01
Date Added to Maude2019-02-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameESOPHYX DEVICE
Generic NameENDOSCOPIC SUTURE/PLICATION SYSTEM GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Product CodeODE
Date Received2019-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerENDOGASTRIC SOLUTIONS, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-01-31

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