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 Laceration(s) of Esophagus (2398); Perforation of Esophagus (2399)

Event Date 11/14/2022

Event Type  Injury  

Event Description

A patient underwent a laparoscopic hiatal hernia repair procedure followed by a tif procedure.On removal of device, the physician noted abnormal resistance.An endoscope was inserted into the patient's esophagus after the tif procedure and a perforation was observed 3cm above the gastroesophageal junction.The physician decided it was best to locate a cardiothoracic surgeon at a nearby hospital to repair the perforation.The physician reports that the perforation was surgically repaired, and the patient is doing well as of 16 november 2022.

Manufacturer Narrative

The physician is not alleging a product malfunction caused or contributed to the patient adverse event and the device has not been returned to endogastric solutions (egs) for evaluation.The device is currently being held at the medical facility by the hospital staff for evaluation.Egs has made multiple written attempts to obtain additional information from the physician, and no additional information has been provided to egs to date.A follow up report may be submitted if additional information is obtained.Based on the available information currently received by egs, the cause of the reported esophageal perforation cannot be conclusively determined.It cannot be conclusively determined if the hiatal hernia repair procedure, tif procedure, or a combination of both procedures contributed or caused or this adverse event.

Manufacturer Narrative

Updated complainants name.

Event Description

The physician performed savary dilation of the esophagus at 18mm and 20mm prior to introducing the esophyx device.An esophageal tear is now being reported as the observed patient impact 3cm above the gastroesophageal junction.

Manufacturer Narrative

Updated problem description, adverse events term, health effect -clinical code, and manufactures narrative based on information received by physician.The physician is alleging the tif procedure may have contributed or caused the reported esophageal tear.In the initial report received by egs (endogastric solutions) a perforation was reported.The physician is now reporting an esophageal tear as the associated harm, thus no perforation is associated with this adverse event.Additionally, the system manager, risk management & patient safety at the medical facility has confirmed the esophyx device will not be returned to egs for evaluation.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.It cannot be conclusively determined if the hiatal hernia repair, pre-tif egd, esophageal savary dilation at 18mm and 20mm, tif procedure, post-tif egd or a combination of events, contributed or caused the adverse event.

• 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: 15983979
• MDR Text Key: 305494305
• Report Number: 3005473391-2022-00174
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)230126(10)403063
• 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: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 82 KG