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

Model Number	R2005
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Firing Problem (4011)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician is alleging a device malfunction causing or contributing to the serious adverse event.The device has not been returned to endogastric solutions, but device return is anticipated.A review of manufacturing records indicate all devices from this product lot released to finished goods inventory passed normal manufacturing final acceptance testing.If the device is returned, a follow-up report will be submitted.
Event or Problem Description
The physician reported a mucosal tear occurred during a concomitant hiatal hernia repair and tif procedure.No medical intervention was performed to treat the mucosal tear and no leaks were noted during the post-procedure egd.The procedure was successfully completed using a secondary esophyx device.The day after the procedure the patient returned to the hospital and emergency surgery was performed to treat esophageal and gastric leaks.The patient was subsequently discharged on an unknown date.The physician alleges a stylet punctured the tissue multiple times without a fastener, thus contributing to the noted leaks.
Additional Manufacturer Narrative
The device was evaluated at endogastric solutions.A device malfunction was confirmed that may have caused or contributed to fastener delivery issues.No definitive root cause was identified for the device issue noted by the physician.

• 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: 8890520
• Report Number: 3005473391-2019-00123
• Device Sequence Number: 11516018
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190718(10)402495
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2019
• Device Model Number: R2005
• Device Catalogue Number: R2005
• Device Lot Number: 402495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: 49 YR
• Patient Weight: 100