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

Model Number R2007

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

This initial mdr was originally submitted to the fda on 09/29/2018.Endogastric solutions received a notification from the fda on 05/02/2023 stating this initial report was missing.This report is being submitted retrospectively per fda request.The physician is alleging a device malfunction caused and/or contributed to the reported event.The device is currently being held at the medical facility and will not be released to endogastric solutions (egs); a representative from egs will perform a limited evaluation on the device at the medical facility and a follow-up report will be submitted once the evaluation is complete.

Event Description

After successfully completing the tif procedure, the physician reported difficulty removing the device from the stomach and noted the endoscope was protruding from the tissue mold elbow.The endoscope was retracted into the device (the exact location was not reported) and the device was withdrawn until it became stuck in the proximal esophagus.The patient's endotracheal cuff was deflated, yet the device remained unable to be removed and the endoscope was unable to be advanced, retracted nor rotated.In an attempt to understand the issue, a small endoscope was inserted by a second anesthesiologist alongside the device, but visualization was not achieved.The second anesthesiologist then placed their fingers inside the patient's throat, near the proximal esophagus, attempting to remove the device.The endoscope was freed and removed from the device and the device was then easily removed.It was noted the jacket of the endoscope was damaged and looked "accordioned".A post procedure egd was performed and the physician noted the patient's esophagus was irritated (no other patient impact was noted).The decision was made to hospitalize the patient and a 1cm mucosal tear on the posterior wall of the cervical esophagus (around the upper esophageal sphincter) was diagnosed and no medical/surgical intervention was performed.

• Brand Name: ESOPHYX Z+
• Type of Device: ODE
• Manufacturer (Section D): ENDOGASTRIC SOLUTIONS, INC.; 18109 ne 76th st.; 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: 8031112
• MDR Text Key: 314385606
• Report Number: 3005473391-2018-00114
• Device Sequence Number: 1
• Product Code: ODE
• UDI-Device Identifier: 00810275011089
• UDI-Public: (01)00810275011089(17)200412(10)402609
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2018

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 Expiration Date: 04/12/2020
• Device Model Number: R2007
• Device Catalogue Number: R2007
• Device Lot Number: 402609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2018
• 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
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White