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

Model Number	C02042-01
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
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.Bleeding was not identified until patient was back in room.Post operative scans and exam did not reveal the bleeding site, which resolved on its own.The physician reported the patient was doing well and was released on the fourth day.
Event or Problem Description
The company sales rep reported that in an email correspondence with the physician, it was mentioned the tif patient, who would normally spend one night in the hospital following the procedure, had spent several more days due to bleeding.There was no allegation of device malfunction.The device was discarded by the hospital after the successful procedure.Bleeding was identified after the patient was back in her room.Post procedure exams/testing showed no further bleeding and no specific bleeder site was found.The bleeding resolved on its own.

• 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: 5501638
• Report Number: 3005473391-2016-00095
• Device Sequence Number: 18902560
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)YYMMDD(10)XXXXXX
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 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: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2016
• 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: 35 YR
• Patient Weight: 46