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 Codes	Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399); Respiratory Failure (2484)
Date of Event	02/13/2024
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 esophageal tear, subsequent perforation, or leak.The device was discarded at the medical facility and is unavailable for return to endogastric solutions (egs).The physician reported the esophageal tear being present prior to the introduction of the esophyx device after use of the bougie with guidewire.Based on the available information received by egs, the cause of the reported esophageal tear and subsequent perforation, and leak may be due to the use of the wire guided bougie or hhr.No root cause was identified; thus, it is unknown if the hhr procedure, tif procedure, use of the bougie with guidewire, 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 with a guidewire was used prior to the insertion of the esophyx device to dilate the esophagus.During the pre-tif esophagogastroduodenoscopy (egd), prior to the insertion of the esophyx device, an esophageal tear was noted at the distal esophagus.The physician proceeded with the tif procedure, despite the noted tear, and uneventfully completed the tif procedure.During the post-tif egd, the previously noted esophageal tear was now noted as an esophageal perforation.It was also noted that three anterior fasteners had been torn out; the fasteners were still in the stomach but had pulled out of the esophagus.The physician placed sutures at the site of the perforation, and a drain was placed intra-abdominally.The patient was admitted to the icu.The patient was extubated, a chest tube was placed, and the patient was re-intubated.On of (b)(6) 2024, the patient underwent an egd, and the noted perforation is still leaking.As of (b)(6) 2024, the patient was discharged from the hospital and is doing well.
Additional Manufacturer Narrative
Corrections to this medwatch report: d6a - implant date was added b2: life threatening updated g3- date received by manufacturer merit medical updated/replaced g code to include 788, 810 updated e code to include 2484 updated/replaced f code to include 4607, 4617, 4624, 4641 replaced b code to include 4114 replaced c code to include 3221 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: 18918841
• Report Number: 3005473391-2024-00213
• Device Sequence Number: 20525446
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250810(10)403604
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/19/2024

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: 08/10/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403604
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• 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: 08/10/2023
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male