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

Model Number R2007

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930); Perforation (2001); Laceration(s) of Esophagus (2398)

Event Date 10/27/2021

Event Type  Injury  

Event Description

A patient underwent a hiatal hernia repair procedure followed by a tif procedure.A bougie was used prior to insertion of the esophyx device and no issues were noted during the tif procedure until device removal.The physician noticed resistance during device removal and noted the tissue mold knob was not properly oriented with the patient's left shoulder.The device was properly re-positioned and the device was successfully removed.An esophageal laceration in the upper esophagus was noted during the post-tif egd.The patient was admitted to the hospital for two days post-op and was discharged with a soft abdomen and some noted pain when touching the epigastrus.Four days post-procedure, the patient returned to the hospital with acute abdominal pain and fever.The patient was subsequently diagnosed with an infection and a micro-esophageal perforation.A ct scan performed on an unknown date showed inflammatory changes and small bubbles beside the fundoplication site.An exploratory laparoscopy was performed, and puss was seen beside the crura and the liver, beside the posterior part of the esophagus, but no perforation was found."stitches" were removed and "blue metilene liquid" was seen coming from the posterior and anterior stitches.A laparoscopic nissen fundoplication was subsequently performed, and antibiotics administered.The physician reported the esophagus was slightly pulled during removal of the esophyx device thus likely causing/contributing to the micro-perforation.

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 that difficulty in removing the device caused/contributed to the reported micro-perforation and subsequent infection.As reported by the physician, the device was not properly oriented during device removal, as required by the product ifu and physician training documents.It is unknown if the hiatal hernia repair or the bougie or the procedure for removal of esophyx device caused or contributed to the reported esophageal laceration.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 events reported herein.

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 that difficulty in removing the device caused/contributed to the reported micro-perforation and subsequent infection.As reported by the physician, the device was not properly oriented during device removal, as required by the product ifu and physician training documents.It is unknown if the hiatal hernia repair or the bougie or the procedure for removal of esophyx device caused or contributed to the reported esophageal laceration.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 events reported herein.

Event Description

A patient underwent a hiatal hernia repair procedure followed by a tif procedure.A bougie was used prior to insertion of the esophyx device and no issues were noted during the tif procedure until device removal.The physician noticed resistance during device removal and noted the tissue mold knob was not properly oriented with the patient's left shoulder.The device was properly re-positioned and the device was successfully removed.An esophageal laceration in the upper esophagus was noted during the post-tif egd.The patient was admitted to the hospital for two days post-op and was discharged with a soft abdomen and some noted pain when touching the epigastrus.Four days post-procedure, the patient returned to the hospital with acute abdominal pain and fever.The patient was subsequently diagnosed with an infection and a micro-esophageal perforation.A ct scan performed on an unknown date showed inflammatory changes and small bubbles beside the fundoplication site.An exploratory laparoscopy was performed, and puss was seen beside the crura and the liver, beside the posterior part of the esophagus, but no perforation was found."stitches" were removed and "blue metilene liquid" was seen coming from the posterior and anterior stitches.A laparoscopic nissen fundoplication was subsequently performed, and antibiotics administered.The physician reported the esophagus was slightly pulled during removal of the esophyx device thus likely causing/contributing to the micro-perforation.

Manufacturer Narrative

Updating health effect clinical code (e) to only include: 2398, 2001, 1685, 1858, and 1930.Updating health effect impact code (f) to only include: 4641, 4607, and 4625.Updating type of investigation (b) to only include: 4112, 4109, 4110, 4111, and 4115.Updating investigation conclusions (d) to only include: 61, and 18.

• 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: 12914283
• MDR Text Key: 285224010
• Report Number: 3005473391-2021-00159
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)230210(10)403132
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172811
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• 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

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 403132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male