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

Model Number	C02162-01
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	02/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procedure was performed successfully and the device was discarded per hospital policy.There was no allegation of a product malfunction.
Event or Problem Description
A successful tif procedure was performed on (b)(6) 2016 and the device was disposed of per hospital policy.Two days later the physician reported to the egs sales representative the patient was readmitted with chest pain.It was postulated a small leak developed during the procedure, allowing procedure insufflation gas into the mediastinum.A ct scan supported this as it did not show any any pleural effusion or sub-diaphragm air and indicated any leak had resolved on its own.Experience has shown the procedure gas used will absorb after two to three days in most cases.The physician took a position of expectant surveillance with no intervention.A few days later the physician reported the patient was doing well.The gas had absorbed and the patient was discharged.

• Brand Name: ESOPHYX Z
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th street; suite 100; redmond WA 98052 5022
• MDR Report Key: 5502996
• Report Number: 3005473391-2016-00096
• Device Sequence Number: 272614
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)YYMMDD(10)XXXXXX
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2016

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?: No
• Operator of Device: Physician
• Device Model Number: C02162-01
• Device Catalogue Number: R2006
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2016
• Initial Report FDA Received Date: 03/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Weight: 78