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

Model Number	R2006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pleural Effusion (2010); Pneumothorax (2012); No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The attending physician is alleging the tif procedure caused or contributed to the adverse event, however there is no allegation of an esophyx device malfunction causing or contributing the adverse event.No additional information regarding how the tif procedure caused or contributed to the adverse event has been provided.A follow-up report will be submitted if additional information is provided.
Event or Problem Description
A patient was admitted to the hospital the day after a tif procedure.The attending physician stated: "[the] patient was found to have pneumoperitoneum, pneumothorax, and plural effusion tracking to the esophagus resulting in prolonged hospitalization and requiring left vats and decortication, pleurx catheter insertion, and then developed bilateral pulmonary emboli." the patient was subsequently discharged on an unknown date.

• Brand Name: ESOPHYX Z
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st.; suite 100; redmond WA 98052
• MDR Report Key: 8839292
• Report Number: 3005473391-2019-00122
• Device Sequence Number: 2586802
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)190228(10)402437
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: R2006
• Device Catalogue Number: R2006
• Device Lot Number: 402437
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/29/2019
• 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; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 168