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

Model Number	C02260-02
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The procedure was completed successfully and the patient was admitted and discharged (b)(6) 2017 after an esophagram was performed and no issues were identified.The device was available from the hospital for evaluation; an engineering device evaluation was performed on the returned product.Although the customer alleged a device malfunction occurred, no device failure was confirmed during the engineering device evaluation.
Event or Problem Description
The user reported significant resistance while attempting to remove the device from the patient at the end of the procedure.The endoscope was also unable to be removed from the device.More lubricant was added to the device/endoscope interface but the endoscope remained unable to be removed.During this time, it was reported an orange color was seen on the endoscope monitor.A secondary endoscope was inserted and observed the device tissue mold stuck 25-35 degrees from fully open.The first endoscope was able to be pulled back out of the tissue mold after manipulating the endoscope controls.The device was then successfully removed from the patient.During the post-procedure egd, a 2-3 cm long laceration was seen on the esophagus located laterally above the gej (approximately 35-37 cm from the mouth of the patient).The user treated the laceration with 3 endoclips.

• 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: 6487127
• Report Number: 3005473391-2017-00101
• Device Sequence Number: 19132463
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)181104(10)402370
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160960
• 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): 04/12/2017

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: 11/04/2018
• Device Model Number: C02260-02
• Device Catalogue Number: R2006
• Device Lot Number: 402370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/12/2017
• 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: 23 YR
• Patient Weight: 73