MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS INC ESOPHYX Z+; ENDOSCOPIC SUTURE/PLICATION SYSTEM

Catalog Number	R2007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Esophagus (2399); Pleural Empyema (4459)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that a male patient underwent a transoral incisionless fundoplication [tif] procedure for gerd.The patient had a severe cough, that was unrelated to the procedure when discharged from the hospital.The patient presented again 11 days post-tif procedure for a gi perforation on the anterior side of the fasteners.It is unknown what caused or contributed to the fastener failures or the alleged gi perforation.The chest tubes were also placed in this patient to prevent impairment.The device was not returned for engineering observation and there are no additional patient consequences to report.The patient tolerated the procedures and interventions well.
Additional Manufacturer Narrative
A medwatch initial final report is being submitted due to a retrospective review of egs complaints (b)(4).By merit medical's systems inc, (b)(4) pms team for any identified complaint discrepancies requiring submissions, corrections and/or additional information per 21 cfr 803.A reportable event 3500a medwatch was not submitted to the fda for this complaint.The suspect medical device was discarded and was not returned for engineering evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.Reviewed for egs - merit medical systems inc.1600 west merit parkway south jordan, ut 84095 801-253-1600.

• Brand Name: ESOPHYX Z+
• Common Device Name: ENDOSCOPIC SUTURE/PLICATION SYSTEM
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS INC; 18109 ne 76th street; suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS INC; 18109 ne 76th street; suite 100; redmond WA 98052
• Manufacturer Contact: vishnu venkates ; 18109 ne 76th street; suite 100; redmond, WA 98052 ; 4253079248
• MDR Report Key: 20081883
• Report Number: 3005473391-2023-00500
• Device Sequence Number: 20786013
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: Health Professional
• Device Expiration Date: 01/10/2024
• Device Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Male