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

Model Number	R2007
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Mechanical Problem (1384); Retraction Problem (1536); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a transoral incisionless fundoplication (tif) procedure.Throughout the tif procedure, the physician reported issues when delivering fasteners from the esophyx device and troubleshooted the problem.One stylet was reportedly outside of the gray molding and would not retract.The esophyx device was uneventfully removed form the patient.There is no reported patient impact.
Additional Manufacturer Narrative
The returned device was evaluated at merit medical and an adhesive bond between one of the fastener tubes and distal shaft end was found separated.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.There was no reported patient impact associated with this incident and merit medical deemed the incident as non-reportable at the time of the initial complaint.Egs has now determined if there is a recurrence of this malfunction, a serious adverse event may occur.Therefore, this incident is now reportable.
Additional Manufacturer Narrative
This medwatch supplemental report is being submitted for more robust device coding and use of annex a as requested by the fda.Merit medical systems inc.1600 west merit parkway south jordan, ut 84095 (b)(4).Corrections to this medwatch report: updated a codes to include 1536, 1384, and 1670.

• 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: shala famil ; 18109 ne 76th st; suite 100; redmond 98052 ; 4087055521
• MDR Report Key: 20091463
• Report Number: 3005473391-2024-00232
• Device Sequence Number: 7736706
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(11)240319(17)260319(10)403785
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/28/2024

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 Expiration Date: 03/19/2026
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2024
• 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