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

Model Number XTACK-160-H

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

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-resistance met advancing anchor exchange into anchor exchange channel" 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.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.Ensure that there is sufficient space for the needle to open.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint, as there are no other complaints against this lot number and this allegation, af05185.

Event Description

After deploying 1st suture the next suture appeared not to deploy, once the equipment was removed it was discovered that the tack was stuck in the plastic catheter.Surgery was completed with a competitor's device.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 10/apr/2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint as it was a reportable event.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number and this allegation, af05185.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 26/jan/2023.An xtack was returned with a tack stuck in the liner.There were two tacks and the suture returned.Engineering visually inspected the returned device.Tack number 2 drilled the helix through the channel liner at the bendy portion of the scope.The complaint has been verified as the tack is stuck in the catheter.Lab analysis was able to replicate the reported event of "resistance met advancing anchor exchange into anchor exchange channel", as the tack is stuck in the liner.The user effect of "resistance met advancing anchor exchange into anchor exchange channel" is known and labeled possible adverse event.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 16373086
• MDR Text Key: 309529285
• Report Number: 3006722112-2023-00027
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020763
• UDI-Public: (01)10811955020763(17)20250817(11)20220817(10)AF05185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XTACK-160-H
• Device Catalogue Number: XTACK-160-H
• Device Lot Number: AF05185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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