MAUDE Adverse Event Report: Merit Medical Systems Inc. EsophyX Z+.ESOPHYX; ENDOSCOPIC SUTURE/PLICATION SYSTEM

Catalog Number	R2275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Melena (4480)
Date of Event	08/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported the combined transoral incisionless fundoplication tif with concomitant hernia repair (ctif) procedure was performed on 11aug26 and discharged without sequelae.Patient reportedly returned ~3 days later (14aug26) to the er with melena where gi noted that one fastener site seemed to have been bleeding, but bleeding was seen to have stopped.Adult upper endoscope that was used at that time didn't retroflex fully so gi couldn't treat area with clips or any other means to ensure hemostasis.Patient was discharged.Patient presented again to the emergency room on (b)(6) 2026 with a hemoglobin of 6.2 and patient was given transfusion of blood and admitted.On (b)(6) 2026, the bleeding was noted to be stopped upon esophagogastroduodenoscopy (egd) and the patient was discharged without additional intervention.The hemoglobin has returned to normal, and the patient is doing great.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the product history and complaint database could not be performed since the lot number was not provided.The investigation is ongoing.If additional reportable information becomes available, it will be submitted in a supplemental report.

• Brand Name: EsophyX Z+.ESOPHYX
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM
• Manufacturer (Section D): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): Merit Medical Systems Inc.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 50896007
• Report Number: 1721504-2026-00442
• Device Sequence Number: 20296684
• Product Code: ODE
• UDI-Device Identifier: 00884450848135
• UDI-Public: 00884450848135
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Catalogue Number: R2275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown