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

Model Number ESS-G02-160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pneumothorax (2012); Perforation of Esophagus (2399)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to the fda.A review of the instructions for use notes the following: the current overstitch¿ endoscopic suturing system (ess) instructions for use (ifu) addressed the known and potential event of "other-clinical outcome device related" as follows: 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.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating, pharyngeal, colonic and/or esophageal perforation, esophageal, colonic and/or pharyngeal laceration, intra-abdominal (hollow or solid) visceral injury.

Event Description

Observed as a distal esophageal perforation and bilateral pneumothorax.Patient was discharged home in a good state 5 days after the procedure.

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on (b)(6) 2020.The device was returned to apollo on (b)(6) 2020.Analysis of the device is ongoing.

Manufacturer Narrative

Supplement #2 medwatch submitted to the fda on 08/oct/2020.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 30/apr/2020.A needle driver and anchor exchange was received for evaluation.The needle body tip appeared to be straight.When the closing lever was depressed, the needle body appeared to rest in a center position within the alignment tube.The endcap holder was installed on the endcap for testing and alignment pin a2 was used.When the handle was depressed, the needle body tip entered the alignment pin hole without bending or flexing.The device locked into place when the closing lever was depressed.An in-house suture anchor was loaded into the 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.At no time during suture enabling sequence did the anchor drop unintentionally from the needle body tip.

• 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: 9955533
• MDR Text Key: 188085795
• Report Number: 3006722112-2020-00051
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Device Lot Number: 2019100320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention