MAUDE Adverse Event Report: Merit Medical Systems, Inc. EsophyX® Z+; Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)

Model Number	A
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Co2 was not delivering into the device.

• Brand Name: EsophyX® Z+
• Common Device Name: Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)
• Manufacturer (Section D): Merit Medical Systems, Inc.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 50818414
• Report Number: 50818414
• Device Sequence Number: 13314713
• Product Code: ODE
• UDI-Device Identifier: 00884450848111
• UDI-Public: (01)00884450848111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/08/2026
• Report Date (Section F): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A
• Device Catalogue Number: R2007
• Device Lot Number: H3514808
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 154 LB
• Date Report Sent to FDA: 09/09/2026