MAUDE Adverse Event Report: ENDOGASTRIC SOLUTIONS, INC ESOPHYX Z+; ODE

Model Number	R2007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported perforation.The device was discarded at the medical facility and is unavailable for return to endogastric solutions (egs).Per the physician the cause of the perforation is unknown.Per the physician, if the device was scrapping at the location of the perforation, it would be evident during the procedure and the device would have needed to be very high in the patient's anatomy to cause a perforation in the observed area.The physician believes the nasogastric intubation tube may have caused or contributed to the perforation.Additionally, the dhr was reviewed, and the dhr was found to be in compliance and no related manufacturing nonconformances were identified.Based on the available information received by egs, the cause of the perforation cannot be conclusively determined.It cannot be conclusively determined if the hhr procedure, use of multiple bougies, tif procedure, or a combination of these contributed to or caused this adverse event.
Event or Problem Description
A patient underwent a ctif procedure consisting of a hiatal hernia repair (hhr) procedure, conducted laparoscopically, followed by a transoral incisionless fundoplication (tif) procedure).One 56fr bougie was inserted to dilate the patient's esophagus, and no issues were noted during the subsequent pre-tif egd.A second bougie (60fr moloney) was then used to dilate the patient's esophagus.The tif procedure was initiated and was started in the anterior position as the posterior position was noted as "collapsed down".A "normal" amount of bleeding was noted after the second fastener delivery in the greater curve.The tif procedure was uneventfully completed and the esophyx device was removed from the patient.During the post-tif procedure egd, blood was noted from a location above where fasteners were delivered closer to the lesser curve.The tif physician unsuccessfully attempted to place clips endoscopically to treat the perforation.Laparoscopically, the perforation was unable to be located by the hhr physician and an incision was made by the tif physician in the patient's stomach and a staple was placed at the site of the perforation.The patient was discharged the day after the ctif procedure and is expected to make a full recovery.
Additional Manufacturer Narrative
This medwatch supplemental 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 corrections/additional information per 21 cfr 803.Merit medical systems inc.(b)(6).Corrections to this medwatch report: d6a - implant date was added updated g3- date received by manufacturer merit medical updated/replaced g code to include: 810, 788 updated/replaced b code to include: 4114 updated/replaced c code to include: 3221 updated/replaced d code to include: 67 updated/replaced f code to include: 4641, 4607.

• Brand Name: ESOPHYX Z+
• Common Device Name: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th street; suite 100; redmond WA 98052
• Manufacturer (Section G): ENDOGASTRIC SOLUTIONS, INC; 18109 ne 76th st; suite 100; redmond WA 98052
• Manufacturer Contact: darin hammers ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 6784279065
• MDR Report Key: 19347058
• Report Number: 3005473391-2024-00219
• Device Sequence Number: 14105349
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)251030(10)403668
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 10/30/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403668
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• 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