MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER; ODE

Device Problem Insufficient Information (3190)

Patient Problems Aspiration/Inhalation (1725); Pneumonia (2011); Ulcer (2274)

Event Date 06/28/2023

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether the device may have caused or contributed to the event as no product has been returned to endogastric solutions (egs) for evaluation.The investigation is ongoing, and a follow-up report will be submitted upon completion of the investigation.This report is based upon information obtained by endogastric solutions, which the company has not been able to fully investigate or verify prior to the date the report was required by the fda.

Event Description

A patient underwent a hiatal hernia repair (hhr) procedure followed by a transoral incisionless fundoplication (tif) procedure and a nondescript product malfunction and adverse events were reported.The reported adverse events are ulceration and aspiration pneumonia.

Manufacturer Narrative

Corrected b3: date of event and b4: date of this report.

Manufacturer Narrative

Updating health effect impact code (f) to only include: 4614, 4641, 4607, 4649, and 4639.Updating type of investigation (b) to only include: 4115, 4112, and 4119.Updating investigation findings (c) to only include: 213.Updating investigation conclusions (d) to only include: 4315.

• Brand Name: ESOPHYX Z+ OR SEROSAFUSE IMPLANTABLE FASTENER
• 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: 17505360
• MDR Text Key: 320862954
• Report Number: 3005473391-2023-00187
• 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,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 07/16/2023; 07/16/2023
• Supplement Dates FDA Received: 11/20/2023; 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Hospitalization