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	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Youtube video complaint was received by the egs team.The account alleges the patient underwent a successful hiatial hernia repair [hhr] and transoral incisionless fundoplutation [tif] procedure.An upper endoscopy was completed after the procedure and blood was leaking into the patient's stomach.The patient was admitted to icu for continued observation, an additional interventional procedure to control the bleeding was deemed necessary.The patient also needed a blood transfusion post-intervention.According to the video, the patient is recovering well.
Additional Manufacturer Narrative
The suspect medical device was not returned for device 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.Should the device return at a later date the complaint will be re-opened.A medwatch initial final report is being submitted due to a retrospective review of egs complaints [3005473391] by merit medical's systems inc, [1721504] pms team for any identified complaint discrepancies requiring submissions, corrections and/or additional information per 21 cfr 803.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: 20049394
• Report Number: 3005413391-2023-00184
• Device Sequence Number: 7959620
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• Combination Product (Y/N): N
• 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: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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 Catalogue Number: R2007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Life Threatening; Hospitalization
• Patient Sex: Unknown