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 Problem Perforation of Esophagus (2399)

Event Date 02/18/2022

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 tif procedure caused/contributed to the perforation.A review of internal non-conformance reports show that no sharp edges were found during distal end component receiving inspections or manufacturing final acceptance testing.There is no evidence to suggest a component or manufacturing defect caused or contributed to the reported esophageal perforation.Lastly, physicians are instructed to "ensure that the patient's esophagus is of sufficient dimension to accommodate the esophyx z+ device before beginning the procedure" and are warned to "do not exert any excess force while attempting device insertion" in the product ifu.In the training document, the physician is instructed to "use only slight forward pressure and if resistance is encountered, stop and assess".Based on the available information received by egs, the cause of the reported esophageal perforation could not be conclusively determined.It cannot be conclusively determined if the robotic hiatal hernia repair procedure, initial egd, tif procedure, or a combination of the procedures caused or contributed to this adverse event.

Event Description

A patient underwent a robotic hiatal hernia repair procedure followed by a tif procedure.An initial egd was performed and upon insertion of the device, the physician noted resistance passing the device through the lower esophagus into the stomach.The tif procedure was uneventfully completed.During esophyx device removal, the physician identified a perforation in the lower esophagus.The physician robotically repaired the perforation and a gastrojejunal (gj) tube was placed.The physician reports the patient is doing well as of (b)(6) 2022.

Manufacturer Narrative

Updating health effect impact code (f) to only include: 4614, 4621, 4641, and 4625.Updating type of investigation (b) to only include: 4112, 4109, 4110, and 4115.

• 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: 13829589
• MDR Text Key: 289861116
• Report Number: 3005473391-2022-00162
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)230825(10)403165
• 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?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 149 KG