MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. SEROSAFUSE IMPLANTABLE FASTENER; ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Model Number R2275

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

After successful completion of a laparoscopic hiatal hernia repair, a transoral incisionless fundoplication procedure was attempted.While the tif procedure was underway, the endogastric solutions esophyx device misfired.The endoscope became lodged in the esophyx device.The esophyx device and endoscope were extubated.Both instruments were extubated successfully in their entirety.The doctor used a new endoscope to confirm that their was no injury to the patient.No harm/injury evident.

• Brand Name: SEROSAFUSE IMPLANTABLE FASTENER
• Type of Device: ENDOSCOPIC SUTURE/PLICATION SYSTEM, GASTROESOPHAGEAL REFLUX DISEASE (GERD)
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st suite 100; redmond WA 98052
• MDR Report Key: 11626877
• MDR Text Key: 244186803
• Report Number: 11626877
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021,03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: R2275
• Device Catalogue Number: R2275
• Device Lot Number: 403070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Date Report to Manufacturer: 04/07/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA