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

Model Number	R2006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a hiatal hernia repair procedure followed by a tif procedure.No issues were noted during the tif procedure until the final stage of device removal where the device became caught on the bite block.A broken small gray piece of plastic was found in patient's soft palate.The device was removed, and the broken piece was uneventfully and successfully retrieved.There is no reported patient impact.
Additional Manufacturer Narrative
The device was evaluated at endogastric solutions (egs) and determined it was likely the device was removed from the patient in an inflexible orientation that upon recent review may potentially cause harm to a patient.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 that if a device removed in an inflexible orientation were to recur, a serious adverse event may occur.This incident is therefore now reportable.
Additional Manufacturer Narrative
Additional device evaluation findings are being provided for this report.The following items were found during the device evaluation at endogastric solutions (egs): the endoscope tube was damaged.The distal end of the device was permanently misaligned from the proximal end.

• Brand Name: ESOPHYX ZR
• 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: vishnu venkatesan ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 4253079248
• MDR Report Key: 12840803
• Report Number: 3005473391-2021-00158
• Device Sequence Number: 4317384
• Product Code: ODE
• UDI-Device Identifier: 00810275011072
• UDI-Public: (01)00810275011072(17)181201(10)402381
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K172811
• 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,Followup
• Report Date (Section B): 04/29/2024

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: 12/01/2018
• Device Model Number: R2006
• Device Catalogue Number: R2006
• Device Lot Number: 402381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: 04/10/2017; Not provided
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/24/2022; 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2016
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Weight: 176 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White