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

Model Number R2007

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

The physician is not alleging the esophyx device malfunctioned thus contributing to or causing the reported adverse event.The esophyx device was discarded at the medical facility by the hospital staff and is unavailable for return to egs for evaluation.The tif physician stated the reported fluid collection was near the liver, however the cause of the fluid collection is unknown.Thus, it is unknown if the tif procedure contributed to and/or caused the fluid collection.Based on the available information received by egs and the medical opinion of the tif physician, the cause of the reported leak and fluid collection near the liver cannot be determined.It cannot be conclusively determined if the hhr procedure, esophageal dilation by bougie, tif procedure, or a combination of events, contributed to or caused the adverse event.Egs is in the process of obtaining additional complaint information from the physician.No additional information has been provided to egs following the preliminary information received on 11 december 2023.A follow-up report may be submitted if additional information is obtained.

Event Description

A patient underwent a ctif procedure (consisting of a hiatal hernia repair (hhr) procedure conducted either laparoscopically or robotically, followed by a transoral incisionless fundoplication (tif) procedure).Prior to insertion of the esophyx device, a bougie was used to dilate the esophagus.No esophyx malfunction or patient issues were noted during or immediately after completion of the tif procedure and the patient was released from the hospital.The patient returned to the hospital citing back pain and fever.The patient underwent an esophagogastroduodenoscopy (egd) on an unknown date and a ct scan with barium swallow on an unknown date.A leak from an unknown area was identified and fluid collection was observed near the liver.Per the physician, there was no evidence of a perforation near the site of the tif procedure.On (b)(6) 2023, the patient underwent a "leak test" and no leaks were detected.Following the leak test, the physician placed a drain to remove the fluid collection.As of 11 december 2023, the patient continues to be monitored.

• Brand Name: ESOPHYX Z+
• Type of Device: 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 ; 8885183636
• MDR Report Key: 18456410
• MDR Text Key: 332209651
• Report Number: 3005473391-2024-00206
• Device Sequence Number: 1
• Product Code: ODE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization