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	11/27/2017
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 control (retractor control knob, retractor system inner slide tube and a portion of the retractor drive cable) were confirmed to be separated from the device.There was evidence the retractor drive cable hockled prior to separation, though the root cause of the hockling is unknown at this time.A review of component records for the retractor control knob, retractor system inner slide tube and retractor drive cable indicate all components were conforming to their specifications.This complaint is being reported because if no intervention is performed, there is a risk of a sharp foreign body remaining inside the patient.
Event or Problem Description
The user reported while attempting to disengage the helical retractor from tissue, the inner slide tube (with the retractor knob) separated from the retractor drive cable and pulled out of the device.As a result, the user intervened by accessing the remaining retractor drive cable and using hemostat clamps to disengage the helical retractor from tissue.The initial device was 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: 7173931
• Report Number: 3005473391-2018-00106
• Device Sequence Number: 1158821
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065(17)190228(10)402429
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/08/2018

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: 02/28/2019
• Device Model Number: C02042-01
• Device Catalogue Number: R2005
• Device Lot Number: 402429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 01/08/2018
• 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