MAUDE Adverse Event Report: ENDO TOOLS THERAPEUTICS S.A ENDOMINA SYSTEM; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Lot Number 0322004P

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 06/09/2023

Event Type  Injury  

Event Description

The provider performed an upper gi endoscopy without difficulty.After this procedure, the provider initiated an endoscopic sleeve gastroplasty, which was terminated prematurely due to bleeding at the posterior wall of the body of the stomach.An artery was clipped, and hemostasis was achieved.During the endoscopic sleeve gastroplasty, the endomina suturing system was utilized.As the gi technician attempted to load a new tape into the endomina device, the needle sheared through the sheath and clipped the patient's artery.The vendor representative trained the gi technician on the device the day prior and informed him to keep the device straight; otherwise, the needle could go through the sheath.According to the gi technician, the vendor representative provided coaching throughout the procedure.The gi technician attempted to follow the vendor representative's instructions.Once it was discovered that the needle had clipped the patient's artery, the procedure was aborted.The vendor representative has the equipment involved in this incident, and at this time it is unclear if this incident is attributable to operator error or an equipment malfunction.Manufacturer response for endoscopic tissue approximation device - tapes, tapes (per site reporter).Unknown.

• Brand Name: ENDOMINA SYSTEM
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): ENDO TOOLS THERAPEUTICS S.A; 350 s main street; suite 309; doylestown PA 18901
• MDR Report Key: 17197536
• MDR Text Key: 317868705
• Report Number: 17197536
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0322004P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2023
• Event Location: Other
• Date Report to Manufacturer: 06/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23360 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White