Description of Event or Problem · 0
ON MAY 30TH, A PATIENT WHO WAS TREATED WITH THE ENDOMINA® SYSTEM IN CARY, NC ON THE 19TH OF MAY COMPLAINED OF UNEXPLAINED FEVER TO PHYSICIAN. AS THE PATIENT LIVES IN THE BOSTON AREA, SHE CONTACTED THE PHYSICIAN THEN WENT TO A LOCAL ER WHERE THEY DIAGNOSED A GASTRIC LEAK WHICH HAD LED TO AN ABSCESS. THE PATIENT TRANSFER TO THE BRIGHAM AND WOMAN HOSPITAL AS THE GASTRO-TEAM THERE HAS A GREAT EXPERIENCE WITH MANAGEMENT OF POST ENDOSCOPIC GASTROPLASTY COMPLICATIONS. THE PATIENT WAS TREATED ENDOSCOPICALLY AND DRAINS WERE PLACED. AT THE GASTROSCOPY IT WAS OBSERVED THAT ONE OF THE SUTURE HAD REOPENED (SUSPENDER) WITHOUT CERTAINTY OF BEING A CONTRIBUTORY FACTOR. IT SEEMS THE ADVERSE EVENT IS LIKELY RELATED TO THE PROCEDURE BUT IS A KNOWN COMPLICATION NO MATTER THE SUTURING DEVICE USED (SIMILAR REPORTS WITH COMPETITOR DEVICES). UP TO DATE, THE PATIENT HAS RECOVERED. AFTER SEVERAL ATTEMPT TO COLLECT DATA ON THE PATIENT AND ON THE DEVICES USED, NO COMPLEMENTARY DATA ARE AVAILABLE. ENDO TOOLS THERAPEUTICS PERFORMED A TRACEABILITY EXERCISE AND REVIEW ALL BATCH RECORDS OF BATCHES OF DEVICES SENT TO THE HOSPITAL AND NO SUSPICIOUS INFORMATION WERE FOUND.