MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC SUTURING UNIT

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 10/19/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to the apollo device analysis laboratory on 05/nov/2020.Analysis of the device is ongoing.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" 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.

Event Description

Difficulties in removing the helix from the tissue.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on 09/feb/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2020.One tissue helix was returned with blood/tissue present on the distal end of the coil catheter inside the sheath.The knob was pushed down, and it extended the coil as intended, then the knob was pulled up and the coil retracted into the catheter as intended.During rotation of the knob, the turning knob would stick and become intermittent on rotation.Under microscopic analysis, tissue remnant and brown particulate matter was observed on the control wire, helix crimp tube, and corkscrew-helix.A portion of the brown particulate matter and tissue remnant was cleaned from the end of the corkscrew-helix and the helix tip appeared to be sharp.The complaint was verified as functional evaluation showed the rotation knob was difficult to turn.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING UNIT
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 10871826
• MDR Text Key: 217452085
• Report Number: 3006722112-2020-00113
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 97