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

Model Number R2007

Device Problems Loss of or Failure to Bond (1068); Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at endogastric solutions (egs) and the evaluation confirmed one stylet incorrectly exited the device through the device shaft caused by a failed bond joint.A review of manufacturing, equipment, and validation records for the associated bond joint was conducted.The review indicated the bonding process (including equipment) was in a state of control during the manufacturing of this device lot.There was no reported patient impact associated with this incident and egs deemed the incident as non-reportable at the time of the initial complaint.Egs has now determined that if this malfunction were to recur, a serious adverse event may occur.

Event Description

A patient underwent a hiatal hernia repair followed by tif procedure.During use of the device, the physician noted the device was not delivering fasteners properly.A dry fire was performed and only one stylet was seen properly exiting the device.Upon performing a dry fire, an unknown component appeared to exit the device through the device shaft.The device was uneventfully removed.No patient injury was reported as a result of this malfunction.

Manufacturer Narrative

Updating health effect impact code (f) to only include: 2645, and 2199.Updating medical device problem code (a) to only include: 1068, and 2610.Updating component code (g) to only include: 3194.Updating type of investigation (b) to only include: 10, 4110, 4109, 4112, 4111, and 3331.Updating investigation findings (c) to only include: 3243, and 4253.

• 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: 14812535
• MDR Text Key: 303248015
• Report Number: 3005473391-2022-00165
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)230909(10)403179
• 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: 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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403179
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/25/2022
• Supplement Dates Manufacturer Received: 05/26/2022; 05/26/2022
• Supplement Dates FDA Received: 08/12/2022; 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2021
• 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 Age: 64 YR
• Patient Sex: Female