MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number THX-165-028

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on (b)(6) 2021.A review of the device labeling notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "helix-could not be removed from tissue" and "helix-did not turn properly" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Troubleshooting: helix stuck in tissue: i.Use a suitable accessory through the primary channel to apply counter traction to the tissue around the helix, and pull the helix free.Ii.Once endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the helix.Adverse events possible complications that may result from using the endoscopic suturing system include, but may not be limited to: conversion to laparoscopic or open procedure.Intra-abdominal (hollow or solid) visceral injury.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.

Event Description

Difficulties in removing the helix from the tissue causing a small hole in the stomach.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 25/jun/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2021.Tissue helix returned inserted into the needle driver channel.The channel at the distal end is severely damaged and there is blood present inside the tubing.There are biopsy valves present on both channels.Due to the state the helix was returned in, a functional evaluation could not be conducted.An attempt was made to pull the helix out of the channel; however, it was inter-twined inside the channel.Engineering cut through the channel to retrieve the tissue helix for inspection and found a significant amount of tissue present on the tip.The tissue was removed, and visual observation shows the tip is bent.The complaint has been verified as visual observation shows tissue present on the distal end and the tip is bent.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• MDR Report Key: 11995324
• MDR Text Key: 256239558
• Report Number: 3006722112-2021-00058
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(10)AF03608
• Combination Product (y/n): N
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention