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

Model Number	C02042-01
Health Effect - Clinical Codes	Anemia (1706); Extravasation (1842); Hematoma (1884)
Date of Event	07/05/2016
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
The customer reported that a successful tif and hiatal hernia procedure was completed.The day after the procedure, the patient returned to the hospital with unspecified symptoms.Indication of low hematocrit anemia and hematochezia was noted and the patient was given an unspecified amount of blood.An egd procedure was performed and blood was found in the stomach along with a hematoma with extravasated tissue.The extravasated tissue was successfully cauterized.

• Brand Name: ESOPHYX2 HD
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th street; suite 100; redmond WA 98052 5022
• MDR Report Key: 5784375
• Report Number: 3005473391-2016-00098
• Device Sequence Number: 10934409
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)180125(10)402163
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142113
• 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): 07/11/2016

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 Expiration Date: 01/25/2018
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 07/11/2016
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 108