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

Model Number THX-165-028

Device Problem Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch sent to the fda.Apollo has not received the product at this time.Therefore no analysis or testing has been done.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 "overstitch-suture broke/ cut during exchange" and "helix-could not be removed from tissue" as follows: warning: do not introduce the device with the needle body in its open position.Warning: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Anchor exchange will not install anchor onto the needle body: i.Ensure there is sufficient suture slack and the suture outside endoscope is not entangled.Ii.Ensure anchor exchange is properly positioned in alignment tube of needle driver.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.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Warning: ensure appropriate suture slack has been created for desired suture path and pattern.Advance anchor exchange and/or manipulate endoscope to create suture slack.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.

Event Description

Company representative reported on behalf of health professional via field communication form (fcf), "helix was stuck in patient and had to be forcefully removed from the patient.Suture had to be cut out of patient as it wouldn't transfer to anchor exchange.".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on 14/feb/2020.Additional information: a2, b7, d10, h3, h6, h10.Device evaluation summary: one tissue helix with the distal end of the stainless steel coil exposed from the outer sheath was returned for evaluation.Under microscopic analysis, the corkscrew-helix tip appeared to be sharp.When the rotation knob was rotated clockwise and counter-clockwise, the stainless steel coil rotated.The rotation knob was pulled from the helix handle; the wire was engaged to the knob.The returned helix performed as intended.A suture anchor was received connected to the returned anchor exchange.The suture anchor was removed from the anchor exchange for visual evaluation.Under microscopic analysis, the tip and body of the anchor appeared to be straight and not bent and there were no visual voids or discoloration on the anchor body weld.The chamfer was observed to be near full wall thickness and the pin was observed to be bottomed out in the cutout and contacted in the leaf spring.The suture was observed through the suture window and there were no discrepancies.The tab is straight; the die hits the tab in the center and the tab is not bent sideways.A needle driver and anchor exchange was received for evaluation.The endcap holder was installed on the endcap for testing and an alignment pin was used.When the handle was depressed, the needle body tip entered the alignment pin hole without bending or flexing.The returned suture anchor was loaded into the returned anchor exchange, and the exchange was advanced into the endcap holder.When the needle driver was actuated, the anchor engaged to the needle body.This test was successfully repeated several times.The anchor exchange release button was within the appropriate travel distance of the release handle.Under microscopic analysis, the inside of the receptacle was observed while pressing the release button.The latch, hard stop, and opener were all observed; the opener passed under the latch while advancing towards the distal end of the receptacle.The returned anchor was inserted into the receptacle for testing; when the release button was pressed, the anchor released.Under microscopic analysis, the surface components of the needle driver and anchor exchange that interface with the suture were not observed to have any sharp features.The suture anchor was installed onto the needle body.A force-gauge was attached to the endcap, and the suture anchor was pulled from the needle body by the anchor exchange and met specifications.The reported complaint could not be verified as all returned devices performed as intended.

• 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 78746
• MDR Report Key: 9558865
• MDR Text Key: 183978748
• Report Number: 3006722112-2020-00002
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR