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

Model Number	R2007
Medical Device Problem Codes	Contamination (1120); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A 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 egs medwatch report: b.3 - updated approx date of event.B.7 history updated to include hiatal hernia gerd d6a - implant date added updated g code to 788 updated b code to include 4117 replaced c code to include 3221 updated d code to include 67 h.8 updated to reflect [x] initial use.
Event or Problem Description
Prior to the tif procedure the patient was noted to have had a consistent hiccup for one year preceding the tif procedure.Additionally, the patient was noted to have grade c esophagitis which is a contraindication for the tif procedure.The patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted laparoscopically, followed by a transoral incisionless fundoplication (tif) procedure).Following the ctif procedure, the patient was experiencing pain and was kept for observation.Despite the continued pain, the patient was discharged from the hospital after five days following the hhr and tif procedures.The patient continued to experience the same pain noted immediately post ctif, visited, and was admitted to a second medical facility (admission date unknown).Additionally, at the second medical facility, the patient was retching and the hiccups persisted.The patient underwent a ct scan on an unknown date and was diagnosed with an abscess.
Additional Manufacturer Narrative
The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported abscess and the device has not been returned to endogastric solutions (egs) for evaluation.The esophyx device was discarded at the original medical facility by the hospital staff.The physician believes a displaced fastener and bacterial translocation from seating the mesh may have caused or contributed to the abscess.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.It cannot be conclusively determined if the hhr procedure, tif procedure, use of bougies, or a combination of events contributed to or caused this adverse event.A follow up report will be submitted if additinoal information is received.
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, 801-253-1600.Corrections to this medwatch report: updated f codes to include:4652.Updated a codes to include 2923, 2886, 4001, and 1120.

• 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; redmond, WA 98052 ; 8885183636
• MDR Report Key: 19602150
• Report Number: 3005473391-2024-00226
• Device Sequence Number: 17002617
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)251213(10)403704
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2024

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: 12/13/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403704
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/17/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male