MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. ESOPHYX2 PLUS; ODE

Model Number C02033-01

Device Problem Insufficient Information (3190)

Patient Problem Pleural Effusion (2010)

Event Date 01/20/2015

Event Type  Injury  

Event Description

It was reported the patient originally underwent a successful tif procedure and was released the following day per normal procedure.Four days later the patient was re-admitted to the hospital for testing for a potential pleural effusion.A chest tube was placed to drain any fluid and was subsequently removed.The patient is doing well.

Manufacturer Narrative

Initial procedure was successful, with no allegation of product malfunction therefore the device was disposed of per the hospital's standard operating procedure.

• Brand Name: ESOPHYX2 PLUS
• 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 street; suite 100; redmond WA 98052
• Manufacturer Contact: james brooks ; 8210 154th ave ne; redmond, WA 98052 ; 4253079233
• MDR Report Key: 4509059
• MDR Text Key: 5405363
• Report Number: 3005473391-2015-00092
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: C02033-01
• Device Catalogue Number: R2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 64