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

Model Number R2007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Esophagus (2399)

Event Date 08/15/2022

Event Type  Injury  

Event Description

A patient underwent a laparoscopic hiatal hernia repair (hhr) procedure followed by a tif procedure where a bougie was used prior to insertion of the esophyx device.The tif procedure was successfully completed, and no issues were noted during the procedure or the post-tif egd.Three weeks post procedures, the patient presented at a second medical facility and was diagnosed with a distended stomach.The patient was transferred back to the initial medical facility where the tif physician noted three micro perforations.All micro perforations were treated endoscopically with sutures and clips.The patient was subsequently discharged and is reportedly doing well.

Manufacturer Narrative

The physician is not alleging the esophyx device malfunctioned thus contributing or causing the reported patient adverse event and the device was not returned to endogastric solutions (egs) for evaluation.The device was discarded at the medical facility by the hospital staff and is unavailable for return to egs.The physician is alleging the tif procedure may have contributed or caused the reported micro perforations.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 laparoscopic hiatal hernia repair, pre-tif egd, esophageal dilation by bougie, tif procedure, post-tif egd or a combination of events, contributed or caused the adverse event.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2399.Updating health effect impact code (f) to only include: 4614, 4621, 4641, and 4607.Updating type of investigation (b) to only include: 4112, 4109, 4110, 3331, 4115, 4111.

• Brand Name: ESOPHYX Z+
• Type of Device: 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: vishnu venkatesan ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 4253079248
• MDR Report Key: 15534536
• MDR Text Key: 301107610
• Report Number: 3005473391-2022-00172
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)231116(10)403224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 151 KG