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	04/12/2023
Type of Reportable Event	Serious Injury
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 (b)(4) by merit medical's systems inc, [1721504] pms team for any identified complaint discrepancies requiring corrections/additional information or submissions per 21 cfr 803.Merit medical systems inc.(b)(6).
Event or Problem Description
The account alleges that the patient underwent a successful transoral incisionless fundoplutation [tif] procedure and was discharged to home with no patient symptoms.The patient returned to the hospital at a later date and was diagnosed with orthostatic hypotension.The patient's hematocrit was also low after blood testing.An upper endoscopy was completed and blood was identified in the patient's stomach.The patient was admitted overnight for observation.No interventions were deemed necessary.April 12, 2023, the patient was doing fine and is recovering well.

• 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: 20052078
• Report Number: 3005413391-2023-00181
• Device Sequence Number: 15427807
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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 Expiration Date: 09/28/2024
• Device Catalogue Number: R2007
• Device Lot Number: 403434
• 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: 08/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown