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

Model Number	R2007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician is not alleging a product malfunction contributed to or caused the adverse event and the device was not returned to endogastric solutions (egs) for evaluation.The device was discarded at the medical facility by hospital staff and is unavailable for return to egs.Based on the available information received by egs, the cause of the pleural effusion cannot be conclusively determined.It cannot be conclusively determined if the hhr procedure, tif procedure, or a combination of both these contributed to or caused this adverse event.
Event or Problem Description
A patient underwent a hiatal hernia repair (hhr) procedure followed by a transoral incisionless fundoplication (tif) procedure.At least one bougie was used to dilate the esophagus prior to the insertion of the esophyx device.Following an unknown span of time post-tif procedure, the patient was admitted on an unknown date to the intensive care unit, diagnosed with a pleural effusion, and underwent video-assisted thoracic surgery (vats) on (b)(6) 2024.As of (b)(6) 2024, the patient is doing well and has been discharged 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.Updated/replaced f code to include: 4607.

• 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 ; 4253079201
• MDR Report Key: 19441929
• Report Number: 3005473391-2024-00222
• Device Sequence Number: 8129692
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250928(10)403643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 09/28/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403643
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female