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 Chest Pain (1776); Fever (1858); Perforation of Esophagus (2399)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Endogastric solutions initially became aware of a potential adverse event on 22 march 2022.After multiple documented attempts to obtain information, it was not until 18 may 2022 when this adverse event was confirmed by the physician.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 esophageal leak as well as the reported uncontrollable retching and vomiting after the procedure.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.

Event Description

The physician stated a patient who underwent a successfully completed tif procedure experienced uncontrollable retching and vomiting in the recovery room post procedure.The patient was readmitted three days post tif after experiencing fever and chest pain where they underwent a ct scan as well as a esophogram.An esophageal stent was placed to treat the distal esophageal leak six days post tif.The patient was admitted again twenty-nine days post tif to treat a dislodged esophageal stent.The patient is reportedly doing well as of (b)(6) 2022.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2399, 1776, and 1858.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, 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: 14500136
• MDR Text Key: 294780578
• Report Number: 3005473391-2022-00164
• Device Sequence Number: 1
• Product Code: ODE
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 51 KG