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 Chest Pain (1776); Perforation (2001)

Event Date 04/19/2021

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 unable to confirm whether the hiatal hernia repair procedure and/or tif procedure caused or contributed to the patient's adverse event.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 to address a 6cm hernia, followed by a tif procedure.A 60fr bougie was used prior to inserting the esophyx device and the tif procedure was completed.No patient injury was identified during or immediately after the procedures.The day after the procedures, the patient presented with chest pain and a ct scan was performed.The ct scan showed a perforation of unknown size in the area of the cardia, in the posterior aspect.The patient underwent an additional procedure to treat the perforation and stitches from the hiatal hernia repair were also seen torn out of the right arm of the crus.This was repaired during the same procedure.Additionally, multiple fasteners on the posterior aspect of the esophagus were seen "dangling" and were removed laparoscopically.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2001, and 1776.Updating health effect impact code (f) to only include: 4625, and 4607.Updating type of investigation (b) to only include: 4112, 4109, 4110, 4115, and 4111.Updating investigation conclusions (d) to only include: 4315.

• 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: 11849607
• MDR Text Key: 251451963
• Report Number: 3005473391-2021-00149
• 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

• Date FDA Received: 05/19/2021
• 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
• Date Manufacturer Received: 04/21/2021
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 130 KG