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 Pain (1994); Perforation (2001); Pleural Effusion (2010); Perforation of Esophagus (2399)

Event Date 06/16/2022

Event Type  Injury  

Event Description

A patient underwent a laparoscopic hiatal hernia repair procedure followed by a tif procedure.No issues were noted during the tif procedure nor during the post-tif egd.The patient was npo after the procedures.The following day, the patient was consuming clear fluids and complained of pain.A ugi series followed by a ct scan was completed and an esophageal perforation in an unknown location was identified as well as a loculated pleural effusion.The perforation was repaired laparoscopically, and mediastinal drains and a chest tube were placed.The patient also underwent vats with decortication to treat the pleural effusion.The patient has reportedly made a full recovery as of (b)(6) 2022.

Manufacturer Narrative

The physician is not alleging a product malfunction contributed or caused to the patient adverse event.The device was discarded at the medical facility by the hospital staff and is unavailable for return to endogastric solutions (egs).The physician stated the perforation and subsequent pleural effusion may have occurred during the laparoscopic hiatal hernia repair procedure, the tif procedure, or a combination of traction forces.Based on the available information received by egs, the cause of the reported perforation could not be conclusively determined.It cannot be conclusively determined if the laparoscopic hiatal hernia repair procedure, pre-procedure egd, tif procedure, post-procedure egd, or a combination of events, contributed or caused the adverse event.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2010, 2399, and 1994.Updating health effect impact code (f) to only include: 4625, 4614, and 4607.Updating type of investigation (b) to only include: 4115, 4111, 4112, 4109, and 4110.Updating investigation conclusions (d) to only include: 4315.

• 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: 15218577
• MDR Text Key: 297801203
• Report Number: 3005473391-2022-00169
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)231020(10)403212
• 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 Expiration Date: 10/20/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 172 KG