MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC. ESOPHYX Z; ODE

Model Number	R2006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physician confirmed the placement of the clips to treat the mucosal tear was out of an abundance of caution and not to preclude permanent damage to a bodily structure or function.The physician also confirmed the patient's hospitalization was out of an abundance of caution and not to preclude permanent damage to a bodily structure or function.The device was unable to be evaluated by endogastric solutions as the device was discarded at the medical facility.A review of manufacturing records for the product lot indicate no similar/related manufacturing non-conformance's written for this product lot and all manufacturing equipment was properly maintained and functioning.No root cause has been identified for the noted device failure.This is being reported as intervention was required to safely remove the device from the patient and a serious adverse event may occur if this device failure were to recur.
Event or Problem Description
During a tif procedure, the physician reported the device became stuck in the patient's throat during device removal.The bailout procedure in the product ifu was performed and the retractor cable was also cut to facilitate device proximal end (i.E.Device handle and shaft) removal.The device shaft was removed from the patient.The distal end of the device remained inside the patient's throat.An ent physician was contacted and the distal end was uneventfully removed through the patient's mouth.A post-procedure egd was performed and a 2-3cm long mucosal tear was identified approximately 38cm from the patient's incisors.The physician treated the mucosal tear by using clips.The patient was admitted to the hospital.

• Brand Name: ESOPHYX Z
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st.; suite 100; redmond WA 98052
• MDR Report Key: 9205696
• Report Number: 3005473391-2019-00126
• Device Sequence Number: 3107263
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)191011(10)402512
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• 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): 10/17/2019

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: Health Professional
• Device Expiration Date: 10/11/2019
• Device Model Number: R2006
• Device Catalogue Number: R2006
• Device Lot Number: 402512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/17/2019
• 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: 67 YR
• Patient Weight: 95