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

Model Number	C02260-02
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, egs was notified the patient was diagnosed with a pneumothorax.The tif physician was unsure if the pneumothorax was caused by the medium thickness laceration or the hiatal hernia repair.It is the egs chief medical officer's medical opinion that a medium thickness esophageal laceration will not cause or contribute to air leaking into the chest cavity.The device was unavailable for evaluation; however, the customer verbally stated he is not alleging any product malfunction causing or contributing to the adverse event.
Event or Problem Description
A hiatal hernia repair was performed concomitantly to a tif procedure.While inserting the esophyx z device with a pediatric endoscope, the customer noted the endoscope retroflexed in the patient's esophagus.The device and endoscope were removed from the patient.The customer attempted a second insertion with the endoscope extended past the end of the tissue mold approximately 1cm, when resistance was encountered.The device and endoscope were again removed from the patient.An egd was then performed and nothing was found, though an esophageal perforation was suspected approximately between 11-15cm from the patient's incisors.The procedure was aborted and the patient was transferred to another medical facility.A ct scan with contrast was performed (b)(6) 2018 and the results were interpreted as a full thickness esophageal perforation.A thoracic surgeon performed an exploratory surgery (b)(6) 2018 to inspect the esophagus.No perforation was found but a 4cm medium thickness esophageal laceration was noted.The thoracic surgeon left a drain and ng tube in the patient.The patient remained in the hospital as of (b)(6) 2018.

• Brand Name: ESOPHYX Z
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th street; suite 100; redmond WA 98052
• MDR Report Key: 7301764
• Report Number: 3005473391-2018-00107
• Device Sequence Number: 1893201
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)191011(10)402510
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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 Expiration Date: 10/11/2019
• Device Model Number: C02260-02
• Device Catalogue Number: R2006
• Device Lot Number: 402510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/27/2018
• 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: 67 YR
• Patient Weight: 85