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 Code	Perforation (2001)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
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.An initial report was not submitted or failed to pass submission for this event.The suspect medical device 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.
Event or Problem Description
The account alleges that a patient underwent a hiatial hernia repair [hh] and transoral incisionless fundoplication [ctif] procedure.A 60f bougie was used to streach the esophagus prior to hh repair.The patient returned to the hospital on an unknown date due to back pain and a fever.Following admittance, the pt received an egd with no noted issues on an unknown date, and ct scan with barium swallow on an unknown date.The pt was subsequently diagnosed with a leak from an unknown area with fluid collection being detected near the liver.The physician alleges that there is no evidence of perforation near the site of the tif.(b)(6) 2023, the physician placed a drain for fluid collection.The cause of the fluid collection is unknown.The device was discarded at the facility with no addition patient consequences to report.

• 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: 20082527
• Report Number: 3005473391-2023-00206
• Device Sequence Number: 20723254
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• 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
• Device Implanted Year: 2023
• 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: 07/31/2025
• 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: 07/31/2023
• 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: Unknown