MAUDE Adverse Event Report: ENDO TOOLS THERAPEUTICS S.A TAPES PART OF ENDOMINA SYSTEM

Model Number IA-TAGXDELIXSYS-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 05/30/2023

Event Type  Injury  

Event Description

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.

• Brand Name: TAPES PART OF ENDOMINA SYSTEM
• Type of Device: TAPES
• Manufacturer (Section D): ENDO TOOLS THERAPEUTICS S.A; rue auguste piccard, 48; gosselies, 6041 ; BE 6041
• Manufacturer (Section G): TRANSLUMINAL; 65 boulevard de la moselle; pompey, 54340 ; FR 54340
• Manufacturer Contact: marine rouyer ; rue auguste piccard, 48; gosselies; BE 6041
• MDR Report Key: 17264725
• MDR Text Key: 318549865
• Report Number: 3021721805-2023-07061
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: IA-TAGXDELIXSYS-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female