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

Model Number	C02042-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product.The helical retractor helix and centering needle were found stuck in the tissue mold channel, bent approximately 75° and were protruding from the tissue mold 0.25" - 0.38".A review of the dhr indicates the materials and assembly process were to specifications and passed all final testing criteria.The root cause of the failure could not be definitively determined.There is no reported patient injury; however, if the failure were to recur, it may require intervention to prevent serious injury.
Event or Problem Description
The user reported the helical retractor (both the helix and centering needle) were bent/curved.As a result, the user was unable to engage tissue.The initial device was uneventfully removed and the procedure was successfully completed with a secondary r2005 device.There is no reported patient impact.

• 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: 6967179
• Report Number: 3005473391-2017-00105
• Device Sequence Number: 10868553
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190320(10)402450
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/20/2019
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 81