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 Problems Abscess (1690); Perforation (2001); Perforation of Esophagus (2399)

Event Date 04/19/2022

Event Type  Injury  

Manufacturer Narrative

The physician is not alleging a product malfunction caused or contributed to the patient adverse event and the product 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 caused/contributed to the reported gastric/esophageal leak and abscess after the procedure.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.

Event Description

A patient underwent a hiatal hernia repair followed by tif procedure.The patient returned to the hospital and was diagnosed with a gastric/esophageal leak and an abscess at a fastener location.The physician believes the patient's leak and abscess was caused by the patient "wretching" post-tif procedure.The patient reportedly made a full recovery.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 1690, and 2001.Updating health effect impact code (f) to only include: 4614, and 4607.Updating type of investigation (b) to only include: 4110, 4109, 4112, 4115, and 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: 14838017
• MDR Text Key: 295061154
• Report Number: 3005473391-2022-00166
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)231103(10)403217
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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