MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERTUBE ENDOSCOPIC ACCESS SYSTEM; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number OVT-027-160

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

Patient Problems Pneumothorax (2012); Perforation of Esophagus (2399)

Event Date 03/31/2021

Event Type  Injury  

Event Description

Narrative from staff: the case was booked as an endoscopic revision of gastric bypass.Apollo endo-surgery products were used along with a gastroscope 190 model.A gastroscope 180 was used prior to the 190 scope as a diagnostic scope.After the gastroscope 190 was inserted along with the apollo endoscopic suturing system and the overtube access system, it was discovered that there was an esophageal perforation.It is unknown what the cause of the perforation was.A second surgeon was called to assist with the perforation, and endoscopic clips were placed.During the procedure the patient¿s stats deteriorated, and a code was called.Compressions were given to the patient.It was determined that patient had a tension pneumothorax which was decompressed with a 14g angiocatheter.Chest tubes were then placed bilaterally.The patient¿s stats were then stabilized.Narrative from operative report: surgeon started by cauterizing a dilated anastomosis in a horseshoe type fashion with a biopsy forceps covering approximately 2/3 of the inferior anastomosis.Cautery in this location allows improved plication durability.After 270-degree cauterization of the dilated anastomosis the gastroscope was removed and a well lubricated therapeutic scope inserted transorally into the over tube under direct visualization.This scope had the over stitch device in place which was tested on the back table before insertion.During the insertion of the device an esophageal perforation was noted just distal to the overtube.The device was immediately removed.Manufacturer response for endoscopic access overtube, gastroenterology-urology, overtube endoscopic access system (per site reporter): unsure of response of representative that was in the or during the procedure.Manufacturer response for overstitch sx endoscopic suturing system, (brand not provided) (per site reporter): unsure of response of representative that was in the or during the procedure.

• Brand Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of tx hwy; bldg 1, ste 300; austin TX 78746
• MDR Report Key: 11619016
• MDR Text Key: 243973701
• Report Number: 11619016
• Device Sequence Number: 1
• Product Code: FED
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OVT-027-160
• Device Catalogue Number: OVT-027-160
• Device Lot Number: 2010-2043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26645 DA
• Patient Weight: 88