MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX Z+; ODE

Model Number	R2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported temporary dysphagia.The device was discarded at the medical facility and is unavailable for return to endogastric solutions (egs).Based on the available information received by egs, the cause of the reported temporary dysphagia cannot be determined.No root cause was identified; thus, it is unknown if the use of bougie during the hhr, hhr procedure, tif procedure, use of the bougie prior to the tif procedure, or a combination of events contributed to or caused this adverse event.
Event or Problem Description
A patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted either laparoscopically or robotically, followed consecutively by a transoral incisionless fundoplication (tif) procedure).One bougie was used prior to the insertion of the esophyx device to dilate the esophagus.The tif procedure was completed, and the patient was discharged from the hospital.The patient returned to the hospital on an unknown date and was held for observation complaining of an inability to keep food and liquids down.The patient was initially seen by an er physician and underwent a barium esophagram.The patient was later seen by the tif physician and diagnosed with dysphagia.Following the tif physician's evaluation and patient's overnight stay for observation, the er physician confirmed the patient was able to swallow, keep food and liquid down, and the dysphasia symptoms had resolved.As of (b)(6) 2024, the patient was released from the hospital.
Additional Manufacturer Narrative
This medwatch supplemental report is being submitted due to a retrospective review of egs complaints [(b)(4)] by merit medical's systems inc, [(b)(4)] pms team for any identified complaint discrepancies requiring corrections/additional information per 21 cfr 803.Merit medical systems inc.(b)(6).Corrections to this medwatch report: d6a - implant date was added updated g3- date received by manufacturer merit medical updated/replaced g code to include: 788 updated/replaced b code to include: 4114 updated/replaced c code to include: 3221 updated/replaced d code to include: 67.

• Brand Name: ESOPHYX Z+
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th street; suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th st; suite 100; redmond WA 98052
• Manufacturer Contact: darin hammers ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 6784279065
• MDR Report Key: 18918839
• Report Number: 3005473391-2024-00214
• Device Sequence Number: 6769490
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)240404(10)403301
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403301
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown