MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. ESOPHYX Z; ENDOSCOPIC SUTURE / PLICATION SYSTEM, GASTROESOPHAGEAL REFLUEX DISEASE (GERD)

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2016

Event Type  Injury  

Event Description

A reporter called to report an adverse effect she is experiencing from her esophyxz implant.She had for her gastroesophageal reflux disease.She stated the implant was breaking apart in her stomach and esophagus.In 2017 some of the pieces were removed.She said she is still having fragments in her throughout her stomach and esophagus, but she was told they cannot be taken out.She said the fragments were seen when she had endoscopy.

Event Description

Additional information received from reporter for report mw5109829 on june 6, 2022.

• Brand Name: ESOPHYX Z
• Type of Device: ENDOSCOPIC SUTURE / PLICATION SYSTEM, GASTROESOPHAGEAL REFLUEX DISEASE (GERD)
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.
• MDR Report Key: 14471039
• MDR Text Key: 292498214
• Report Number: MW5109829
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2022
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 95 KG