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 Bacterial Infection (1735); Chest Pain (1776); Perforation (2001); Pleural Effusion (2010); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/19/2021

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 alleging the concomitant procedure may have caused/contributed to the patient's superficial mucosal tear and pleural effusion.The esophyx ifu states: "ensure that the patient's esophagus is of sufficient dimension to accommodate the esophyx z+ device before beginning the procedure." based on the available information received by egs, the cause of the reported incident could not be conclusively determined.It cannot be confirmed whether the robotic hiatal hernia repair, the tif procedure, or a combination of the two procedures caused or contributed to the patient's superficial mucosal tear and pleural effusion.

Event Description

A patient underwent a robotic hiatal hernia repair followed by a tif procedure on (b)(6) 2021.The physician noted the patient had a "tight" esophagus and did not dilate the patient's esophagus prior to inserting the esophyx device.The tif procedure was uneventfully completed.The physician noted the patient had a 3cm superficial mucosal tear in the mid esophagus during the post tif egd.No medical intervention was performed to treat the superficial mucosal tear and the patient was discharged normally post procedures.The patient subsequently presented in the er on (b)(6) 2021 after developing a cough and chest pain.A chest xray and ct scan were performed showed a possible small pleural effusion on the right lung, a small collection of fluid around the gej, and a very small amount of air.The collection of fluid and air were felt to be normal post-op and there was no sign of a leak.The patient was discharged from the er on (b)(6) 2021.The patient was then seen by the physician on (b)(6) 2021 and labs and a chest xray were performed.The patient's right lung showed an effusion thus collapsing the lung with a worsening leukocytosis.The patient was sent back to the er.A percutaneous thoracentesis was performed on (b)(6) 2021 and showed multiple types of cultures present in the patient's right lung.Ct surgery was consulted, and the patient underwent a vats washout and decortication on (b)(6) 2021.The patient recovered well and was discharged on (b)(6) 2021.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2010, 4581, 1776, and 1735.Updating health effect impact code (f) to only include: 4625, 4641, and 4607.Updating type of investigation (b) to only include: 4112, 4109, 4110, 4115, and 4111.Updating investigation conclusions (d) to only include: 4315.

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 a pleural effusion and perforation as the harms associated with this report.As there is no health effect - clinical code for "mucosal tear", code 4581 has been selected for this harm.

• 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: 12200490
• MDR Text Key: 262639571
• Report Number: 3005473391-2021-00153
• 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

• Date FDA Received: 07/20/2021
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 60 KG