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

Catalog Number	R2007
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that the patient underwent a successful transoral incisionless fund oplutation [tif] procedure.The following day the patient presented with hypotensive symptoms and a drop in hemoglobin.An esophagogastroduodenoscopy [egd] was performed demonstrating a gastroesophageal bleed at one of the placement sites of the helical retractor which was reported to be removed without proper disengagement.The physician placed multiple clips at the placement site and was able to control the patient's bleeding.The bleeding did not require a blood transfusion for this patient.On (b)(6) 2023 the patient was reported to be doing 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.

• 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: 20012717
• Report Number: 3005413391-2023-00178
• Device Sequence Number: 17229267
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: 00810275011089
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

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: 09/20/2024
• Device Catalogue Number: R2007
• Device Lot Number: 403394
• 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: 02/24/2023
• Initial Report FDA Received Date: 08/21/2024
• 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: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG