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

Model Number R2007

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Pleural Effusion (2010)

Event Date 02/03/2020

Event Type  Injury  

Manufacturer Narrative

A review of manufacturing records indicates all components and device systems were within specifications.The device was not returned to egs for evaluation thus the reported device malfunction could not be confirmed, and no root cause can be identified for the reported device malfunction.The device was used after the device malfunction was identified and this may have caused or contributed to the fastener delivery issues.

Event Description

A patient underwent a concomitant hiatal hernia repair (hhr) and transoral incisionless fundoplication (tif) procedure on (b)(6) 2020.The customer reported one of the pushers on the esophyx device bent after a fastener delivery was completed.The physician straightened the pusher and two more fastener deliveries were attempted.No fasteners were deployed on the last delivery attempt.During the post-procedure egd, two fasteners were seen hanging from the esophageal tissue in an unknown location.An esophagram was performed the morning after the procedure and was negative for leaks.The patient was discharged approximately a week post-procedure for issues unrelated to the tif procedure.The patient returned to the hospital at an unknown date and a pleural effusion was diagnosed on (b)(6) 2020.The patient was treated, and a drain was placed for approximately 4 days.The patient was subsequently discharged and continues to report symptoms of dysphagia.The physician is unsure if the pleura was punctured by the free-floating legs of the fasteners in the esophagus, post-procedure inflammation, or both.

• Brand Name: ESOPHYX Z
• Type of Device: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st; suite 100; redmond, wa
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st; suite 100; redmond, wa
• Manufacturer Contact: vishnu venkatesan ; 18109 ne 76th st; suite 100; redmond, wa ; 3079248
• MDR Report Key: 9831945
• MDR Text Key: 194776095
• Report Number: 3005473391-2020-00130
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)210510(10)402767
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 402767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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