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

Model Number ESS-G02-160

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problems Suture Abrasion (2497); Patient Problem/Medical Problem (2688)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch submitted 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-mis-aligned needle engagement" 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.Ensure that there is sufficient space for the needle to open.

Event Description

Health professional reported via field communication form, "a bite was taken and needle would not transfer to anchor exchange.Anchor exchange would not move and handle would not move.Vision was lost and paediatric scope was required to have vision and try to move tissue from under needle driver.It is believed that mucosa was jammed under needle driver and anchor exchange and needle driver would not line up leading to jamming of device.Eventually tissue released from under driver and device was able to be dislodged from patient.This took over 2 hours.The patient had 4 clips placed into the tissue that had trauma to ensure no perforation and ensure closure.The esg was not complete and patient will return on another date.Patient was placed on antibiotics." additional information noted: "the needle loaded onto the needle body, took a bite through tissue and the system got completely jammed.[the physician] could not transfer from the needle body to the exchange, the anchor exchange would not advance forward or back and the device was completely stuck.[the physician] also lost vision as there was a red out and could not see what was going on.".

• 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
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: david hooper ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 9546026
• MDR Text Key: 183978377
• Report Number: 3006722112-2019-00172
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2019040691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 108