MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX Z+; ODE

Model Number R2007

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 03/31/2023

Event Type  Injury  

Manufacturer Narrative

The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported esophageal submucosal lining tears.The physician reported one contributing factor may be the patient is a transplant patient.The device was evaluated by endogastric solutions (egs) which confirmed the reported bent helix.All other device systems functioned as designed.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 hhr procedure, bougie dilation of the esophagus, tif procedure, or a combination of events, contributed to or caused the reported adverse event.

Event Description

A transplant patient underwent a hiatal hernia repair (hhr) procedure followed by a transoral incisionless fundoplication (tif) procedure.A bougie was used prior to the insertion of the initial esophyx device and no device issues were noted prior to or during the insertion of the esophyx device.Once the distal end of the esophyx device entered the patient's stomach, the physician noted the helix of the device was bent and chose to continue use of the device to successfully deliver three sets of fasteners.Per the physician, "the helix was stowed correctly when the initial device was removed".A second esophyx device was used to successfully complete the procedure.On removal of the second device, the physician noted two esophageal submucosal lining tears located on opposite sides of the esophagus.The physician determined it was medically necessary to place two clips on the noted tears.As of (b)(6) 2023, the patient is doing well and expected to make a full recovery.

Manufacturer Narrative

Updating health effect impact code (f) to only include: 4614, 4641, and 4621.Updating medical device problem code (a) to only include: 2976.Updating component code (g) to only include: 3123.Updating type of investigation (b) to only include: 4112, 4109, 4110, 3331, 4111, and 10.

• 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: 16837467
• MDR Text Key: 314227736
• Report Number: 3005473391-2023-00180
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250118(10)403481
• 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

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 190 KG