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

Model Number R2007

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

Patient Problems Ischemia (1942); Perforation (2001); Pleural Effusion (2010); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

An endogastric solutions clinical specialist was present during the tif portion of the procedure and did not note any unusual physician technique nor any patient issues during the tif procedure.As per egs policy, egs personnel were not present during the hiatal hernia repair portion of the procedures.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 caused or contributed to the patient's small stomach leak.There is no allegation the tif procedure caused or contributed to the patient's gastric ischemia.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 procedure followed by a tif procedure on (b)(6) 2021 and was still in the hospital as of (b)(6) 2021.No injuries were noted by the physician during or immediately after the procedures.Sometime after the procedures, the patient developed nondescript post-op symptoms.A ct scan was performed on an unknown date and fluid was seen in the patient's chest.An egd was performed on an unknown date and a small leak in the cardia of the stomach near the gej was diagnosed and drains were placed.The patient was additionally diagnosed with gastric ischemia.

Manufacturer Narrative

Endogastric solutions reviewed this event/mdr with dr.Ross segan, md, who provided his medical opinion on the associated harm(s) which should be trended for this event/mdr.Per dr.Segan's medical opinion, the health effect - clinical code field has been updated to reflect pleural effusion, ischemia, and perforation as the harms associated with this report.

• Brand Name: ESOPHYX
• 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: 11810149
• MDR Text Key: 261725261
• Report Number: 3005473391-2021-00147
• 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,Followup
• Report Date: 04/29/2024

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
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 04/13/2021; Not provided
• Supplement Dates FDA Received: 10/18/2022; 04/29/2024
• 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 Sex: Female