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

Model Number	R2007
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated at endogastric solutions (egs) and an adhesive bond between one of the fastener tubes and distal shaft end was found separated.Additionally, multiple partial fasteners were found within the esophyx device, likely caused by the separated adhesive bond.A review of manufacturing records for the associated product lot was conducted, and no nonconformances reports or deviations were found for the affected product lot related to fastener delivery or adhesive bonding issues.Based on this review, there is no evidence to suggest a component or manufacturing defect caused or contributed to reported malfunction.Based on the available information received and engineering evaluation by egs, the cause of the reported incident could not be conclusively determined.There was no reported patient impact associated with this incident and egs deemed the incident as non-reportable at the time of the initial complaint.Egs has now determined if there is a recurrence of this malfunction, a serious adverse event may occur.Therefore, this incident is now reportable.
Event or Problem Description
A patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted either laparoscopically or robotically, followed consecutively by a transoral incisionless fundoplication (tif) procedure).Throughout the tif procedure, the physician reported issues when delivering fasteners from the esophyx device.The initial esophyx device was uneventfully removed from the patient and the tif procedure was successfully completed using a second esophyx device.There is no reported patient impact.
Additional Manufacturer Narrative
A 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.(b)(6).Corrections to egs medwatch report: d6a - implant date added.Updated a code to include 1562.Updated g code to 788.Replaced d code to include 4315.H.8 updated to reflect [x] initial use.

• 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; redmond, WA 98052 ; 6784279065
• MDR Report Key: 19441922
• Report Number: 3005473391-2024-00221
• Device Sequence Number: 12794495
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)250713(10)403593
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K240879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2025
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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
• Patient Sex: Unknown