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

Model Number R2007

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

Patient Problems Abscess (1690); Perforation (2001); Peritonitis (2252)

Event Date 09/22/2021

Event Type  Injury  

Event Description

A patient underwent a hiatal hernia repair procedure followed by a tif procedure.No issues were noted during the tif procedure nor during the post-tif egd.The patient returned to the hospital at an unknown date and was diagnosed with peritonitis and a micro-perforation around a tif fastener site on the gej.The patient was then re-operated on (b)(6) 2021 and (b)(6) 2021 in which a laparotomy with drainage of an abscess, washout, and drain placement with a g-tube and j-tube was completed.The patient was kept npo (nothing by mouth) and enteral nutrition was initiated for 3-weeks.An upper gi was performed the week of (b)(6) 2021 and no evidence of a persistent leak was noted.During the hospitalization, the patient was confirmed as having severe protein and calorie malnutrition prior to the tif procedure.The physician was unaware of the patient's severe malnutrition prior to performing the tif procedure.

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 adverse event and stated, "i suspect her nutritional status contributed to the complication, and suspect that the fundus pulled away from the esophagus and her tissue integrity did not allow her esophagus to heal around the [tif fastener]." the patient's malnutrition was unknown to the physician prior to the hiatal hernia repair procedure followed by a tif procedure.Based on the available information received by egs, the cause of the reported incident could not be conclusively determined.It cannot be conclusively determined if the hiatal hernia repair procedure, tif procedure, or a combination of both procedures caused or contributed to the adverse event.However, as stated by the physician it was noted the patient had severe protein and calorie malnutrition prior to the hiatal hernia procedure followed by a tif procedure, which may have contributed to the adverse event.

Manufacturer Narrative

Updating type of investigation (b) to only include: 4112, 4109, 4110, 4115, and 4111.

Manufacturer Narrative

Updating g7 (adverse event term(s)) and health effect - clinical code (e) to only include: perforation (2001) and peritonitis (2252).

• Brand Name: ESOPHYX
• 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: 12796325
• MDR Text Key: 285465132
• Report Number: 3005473391-2021-00156
• 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,Followup
• Report Date: 04/30/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/11/2021; Not provided
• Supplement Dates FDA Received: 03/01/2024; 04/30/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 127 KG