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	Fistula (1862); Perforation (2001); Fungal Infection (2419)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted robotically, followed consecutively by a transoral incisionless fundoplication (tif) procedure.Both procedures were completed, and the patient returned to the hospital on an unknown date and was admitted due to inability to keep food or liquid down.The patient underwent a ct scan on (b)(6) 2024 which did not reveal a perforation or leak.Following the ct scan, a mediastinal drain was placed on (b)(6) 2024 and a leak was confirmed.After the drain placement and leak confirmation, the patient underwent a surgical procedure by the hhr physician on an unknown date to detect any abnormalities.No abnormalities were noted.On (b)(6) 2024, the patient was still reportedly unable to keep food or liquid down.The patient underwent an esophagogastroduodenoscopy (edg) by the tif physician and was diagnosed with a perforation and esophageal fistula.Clips were placed endoscopically to close the fistula.Following the placement of clips the patient was able to keep food and liquid down.Additionally, cultures which were completed on (b)(6) 2024 showed candida fungus.Thus, the pt was placed on anti-fungal medication to treat the candida fungus.The patient is reportedly recovering and expected to be discharged on (b)(6) 2024.
Additional Manufacturer Narrative
The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported perforation, esophageal fistula, and candida fungus.The device was discarded at the medical facility and is unavailable for return to endogastric solutions (egs).The physician does not believe the tif procedure nor esophyx device caused or contributed to the development of the perforation, esophageal fistula, and development of fungus.Based on the available information received by egs, the cause of the reported perforation, esophageal fistula, and development of fungus cannot be confirmed.It is unknown if the hhr procedure, tif procedure, use of the bougies, or a combination of events contributed to or caused this adverse event.
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 replaced d code to include 67 h.8 updated to reflect [x] initial use.

• 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: 19638633
• Report Number: 3005473391-2024-00227
• Device Sequence Number: 12914242
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)251213(10)403703
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/28/2024

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: 403703
• 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
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female