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

Model Number R2007

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Endogastric solutions (egs) received information that a patient who underwent a transoral incisionless fundoplication (tif) procedure experienced an unknown adverse event.It is unknown whether medical intervention was required to treat the patient.

Manufacturer Narrative

Currently it is unknown whether the esophyx device or tif procedure may have contributed to or caused the reported event.No conclusion can be drawn at this time.Egs is submitting this report to comply with 21 cfr part 803, the medical device reporting regulation.This report is based on limited information received by egs as of the report date, which egs has not been able to fully investigate or verify prior to submitting this report as required by the fda.A follow-up report may be submitted at a later date if additional information is obtained by egs.

Manufacturer Narrative

Updating type of investigation (b) to only include: 4115, 4112, and 4119.Updating investigation findings (c) to only include: 3221.Updating investigation conclusions (d) to only include: 4315.

• 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 ; 4253079201
• MDR Report Key: 17761597
• MDR Text Key: 323576440
• Report Number: 3005473391-2023-00198
• Device Sequence Number: 1
• Product Code: ODE
• 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: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening