ON (B)(6) 2018, EGS WAS NOTIFIED THE PATIENT WAS DIAGNOSED WITH A PNEUMOTHORAX. THE TIF PHYSICIAN WAS UNSURE IF THE PNEUMOTHORAX WAS CAUSED BY THE MEDIUM THICKNESS LACERATION OR THE HIATAL HERNIA REPAIR. IT IS THE EGS CHIEF MEDICAL OFFICER'S MEDICAL OPINION THAT A MEDIUM THICKNESS ESOPHAGEAL LACERATION WILL NOT CAUSE OR CONTRIBUTE TO AIR LEAKING INTO THE CHEST CAVITY. THE DEVICE WAS UNAVAILABLE FOR EVALUATION; HOWEVER, THE CUSTOMER VERBALLY STATED HE IS NOT ALLEGING ANY PRODUCT MALFUNCTION CAUSING OR CONTRIBUTING TO THE ADVERSE EVENT.
D
Patient 1
A HIATAL HERNIA REPAIR WAS PERFORMED CONCOMITANTLY TO A TIF PROCEDURE. WHILE INSERTING THE ESOPHYX Z DEVICE WITH A PEDIATRIC ENDOSCOPE, THE CUSTOMER NOTED THE ENDOSCOPE RETROFLEXED IN THE PATIENT'S ESOPHAGUS. THE DEVICE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT. THE CUSTOMER ATTEMPTED A SECOND INSERTION WITH THE ENDOSCOPE EXTENDED PAST THE END OF THE TISSUE MOLD APPROXIMATELY 1CM, WHEN RESISTANCE WAS ENCOUNTERED. THE DEVICE AND ENDOSCOPE WERE AGAIN REMOVED FROM THE PATIENT. AN EGD WAS THEN PERFORMED AND NOTHING WAS FOUND, THOUGH AN ESOPHAGEAL PERFORATION WAS SUSPECTED APPROXIMATELY BETWEEN 11-15CM FROM THE PATIENT'S INCISORS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL FACILITY. A CT SCAN WITH CONTRAST WAS PERFORMED (B)(6) 2018 AND THE RESULTS WERE INTERPRETED AS A FULL THICKNESS ESOPHAGEAL PERFORATION. A THORACIC SURGEON PERFORMED AN EXPLORATORY SURGERY (B)(6) 2018 TO INSPECT THE ESOPHAGUS. NO PERFORATION WAS FOUND BUT A 4CM MEDIUM THICKNESS ESOPHAGEAL LACERATION WAS NOTED. THE THORACIC SURGEON LEFT A DRAIN AND NG TUBE IN THE PATIENT. THE PATIENT REMAINED IN THE HOSPITAL AS OF (B)(6) 2018.