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 01/18/2022

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 tip of the device caused/contributed to the reported esophageal perforation.A review of component inspection records for the tissue mold tip was conducted, no nonconformance reports related to sharp edges (i.E.Flash, gate vestige, etc.) or dimensions were created for that tissue mold component lot.Additionally, all devices must pass final acceptance testing (fat) where product functionality and sharp edges are inspected before shipment.No nonconformance reports were found for any devices failing fat.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," are warned to "do not exert any excess force while attempting device insertion" in the product ifu, and "use only slight forward pressure and if resistance is encountered, stop and assess" in the physician training document.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 hiatal hernia repair procedure, initial egd, insertion of three different sized bougies used to dilate the esophagus procedure, attempted tif procedure, or a combination of the four procedures caused or contributed to this adverse event.

Event Description

A patient underwent a laparoscopic hiatal hernia repair procedure.An initial egd was performed, then multiple (3 different sizes) bougies were used to dilate the esophagus.A tif procedure had been planned afterwards.Post laparoscopic hiatal hernia repair and insertion of bougies, the physician inserted the esophyx device, with the endoscope leading the esophyx device, into the patient's esophagus and encountered resistance when the tip of the esophyx device was in the distal esophagus.The endoscope was able to successfully pass into the stomach.The endoscope and esophyx device were removed from the patient.The endoscope was reinserted into the esophagus and a perforation at distal end of esophagus was noted.The tif procedure was aborted, and the physician laparoscopically repaired the esophageal perforation.The patient was admitted overnight out of an abundance of caution and discharged the following day.The patient is reportedly doing well as of 02/07/2022.

• 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: 13595068
• MDR Text Key: 287682365
• Report Number: 3005473391-2022-00160
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)230901(10)403168
• 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
• Report Date: 02/23/2022

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: 09/01/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 73 KG