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	04/14/2017
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 retractor control cable was found looped and captured in the tissue mold and the helix coil was elongated.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 determined.(b)(4).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
After deploying two sets of fasteners in one location and moving to a second location, the user reported the helical retractor "felt loose" and "didn't feel right" and made an unsuccessful attempt to engage tissue.Upon visual inspection by the user, it was observed the helix was protruding 90-degrees from the distal end of the tissue mold.An attempt to straighten the helix using the endoscope was unsuccessful.The user subsequently attempted to straighten the helix using the endoscope grasper but was unsuccessful.After the unsuccessful attempts, the endoscope grasper was used to cover the helix to safely remove the device.A secondary r2005 device was used to successfully complete the procedure.There is no reported patient injury.

• 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: 6566068
• Report Number: 3005473391-2017-00102
• Device Sequence Number: 624097
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190112(10)402400
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142113
• 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): 05/13/2017

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: 01/12/2019
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2017
• Initial Report FDA Received Date: 05/13/2017
• 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: 70 YR
• Patient Weight: 62