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

Model Number	C02260-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation of Esophagus (2399)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user verbally stated there is no allegation of device malfunction.The device was received and evaluated by egs and no trouble was found with the device.
Event or Problem Description
Prior to device insertion, the user reported issues with video output from the endoscope.Insertion of the device was initially attempted without endoscopic visualization of the esophagus and the user reported difficulty inserting the device.An egs representative present at the procedure, reported the user used an abnormally large amount of force during insertion.On the third attempt, the device was successfully inserted into the patient but was quickly removed as no endoscopic visualization could be achieved.After fixing the endoscope video issue, the user reinserted the endoscope into the patient and noted blood present in the esophagus.In an attempt to locate the source of the bleeding, the user externally opened the patient's abdomen and neck.A perforation was found in the proximal esophagus mid-chest approximately in the same location as resistance was felt during device insertion.The perforation was successfully treated and the patient was admitted to the icu (b)(6) 2017.As of (b)(6) 2017, the patient was still in the icu in stable condition and continues to improve.The user verbally stated there is no allegation of device malfunction.
Additional Manufacturer Narrative
Errors listed below were found in the initial report and are being corrected in this follow-up report: incorrect brand name was provided (esophyx2 hd) and has been updated to esophyx z.Model #, catalog #, and unique identifier (udi) # were incorrect identified as c02042-01, r2005, and(b)(4).These three fields have been corrected to c02260-02, r2006, and (b)(4) respectively.Pma/510(k) was incorrectly identified as k142113.This has been corrected to k171307.

• Brand Name: ESOPHYX Z
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th street; suite 100; redmond WA 98052 5022
• MDR Report Key: 6662379
• Report Number: 3005473391-2017-00104
• Device Sequence Number: 221082
• Product Code: ODE
• UDI-Device Identifier: 00810275011065
• UDI-Public: (01)00810275011065
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 06/22/2017

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 Expiration Date: 11/23/2018
• Device Model Number: C02260-02
• Device Catalogue Number: R2006
• Device Lot Number: 402375
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/20/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 08/31/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82