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

Model Number ESS-G02-SX1

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 06/jul/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 events of "suture assembly-anchor exchange fails to receive ancho" 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.Warnings: do not use a device where the integrity of the sterile packaging has been compromised or if the device appears damaged.Ensure that there is sufficient space for the needle to open.

Event Description

The anchor exchange failed to capture the anchor back into the receptacle, case was stopped and was not finished.

Manufacturer Narrative

Supplement #1 medwatch submitted to the fda on (b)(6) 2021.Device evaluation summary: the devices were returned to the apollo device analysis laboratory on (b)(6) 2021.Two needle drivers and two anchor exchanges were returned for investigation.The heat shrink on one anchor exchange has been pulled down from the handle.Visual observation shows the catheters are bent near the handle on both returned anchor exchanges.The release buttons were pressed, and they do not fully retract at the distal end.Per engineering, the kinks on the catheters of the anchor exchanges likely caused the friction in the receptacle mechanism.The complaint has been verified due to the anchor exchanges being damaged.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• MDR Report Key: 12122432
• MDR Text Key: 261280783
• Report Number: 3006722112-2021-00057
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• PMA/PMN Number: K181141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: ESS-G02-SX1
• Device Catalogue Number: ESS-G02-SX1
• Device Lot Number: 2020070610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1