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

Model Number R2007

Device Problem Failure to Fire (2610)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

A patient underwent a laparoscopic hiatal hernia repair (hhr) procedure followed by a tif procedure.During use of the device, the physician noted the esophyx device was not delivering fasteners properly.The esophyx device was uneventfully removed from the patient and a second esophyx device was used to successfully complete the procedure.No patient injury was reported as a result of this malfunction.

Manufacturer Narrative

The device was evaluated at endogastric solutions (egs) and the evaluation confirmed a failed adhesive bond between the fastener tube and distal shaft end.A review of manufacturing records is in progress.A follow-up report will be submitted at the conclusion of the investigation.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 subsequently determined that if this malfunction were to recur, a serious adverse event may occur.Therefore, this incident is now reportable.

• 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: 15534534
• MDR Text Key: 306414329
• Report Number: 3005473391-2022-00171
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)240110(10)403251
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2024
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• 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 Sex: Female