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 Atrial Fibrillation (1729); Perforation of Esophagus (2399)

Event Date 05/12/2021

Event Type  Injury  

Event Description

The physician stated a patient who underwent a successfully completed tif procedure returned to the hospital three days post-procedure with chest discomfort and atrial fibrillation.After being admitted to the hospital, the patient underwent a ct scan and barium swallow, and was diagnosed with a distal esophageal leak near the gastroesophageal junction.The patient was subsequently transferred to another medical facility where an esophageal stent was placed.The patient is reportedly doing well as of (b)(6) 2022.

Manufacturer Narrative

Endogastric solutions initially became aware of a potential adverse event on 18 february 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.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2399, and 1729.Updating type of investigation (b) to only include: 4112, 4109, 4110, and 4115.

• 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: 14500126
• MDR Text Key: 292748477
• Report Number: 3005473391-2022-00163
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 54 KG