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 Problems Abdominal Pain (1685); Abscess (1690); Fever (1858); Perforation (2001); Perforation of Esophagus (2399)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

The physician is not alleging a product malfunction caused or contributed to the patient adverse event and the product was not returned to endogastric solutions (egs) for evaluation.The device was discarded at the medical facility by the hospital staff and is unavailable for return to egs.The physician is alleging the tif procedure caused or contributed to the patient's perforation and subsequent abscess.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.

Event Description

Five days post hiatal hernia repair procedure followed by a tif procedure, the patient returned to the medical facility and presented with an abscess, fever, and abdominal pain.A drain was placed to drain the abscess and during the same procedure, a small perforation was found on the distal esophagus (near where the esophagus ends and the gej starts).A fistulagram was performed on an unknown date and the perforation was confirmed and measured approximately 5mm in size.On (b)(6) 2021, the patient underwent a procedure to remove the drain and a stent was placed to treat the perforation.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2399, 1690, 1858, and 1685.Updating health effect impact code (f) to only include: 4624.Updating type of investigation (b) to only include: 4112, 4109, 4110, 4111, and 4115.Updating investigation conclusions (d) to only include: 4315.

• 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: vishnu venkatesan ; 18109 ne 76th st; suite 100; redmond, WA 98052 ; 4253079248
• MDR Report Key: 11829071
• MDR Text Key: 265294862
• Report Number: 3005473391-2021-00148
• 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,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: UNKONWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 36 YR
• Patient Sex: Male