MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-160

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 1/apr/2021.After multiple attempts to gather more information from the reporter, no additional information has been received.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 "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.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.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: nausea and / or vomiting, hemorrhage, aspiration.

Event Description

Literature review reported: the efficacy and safety of endoscopic sleeve gastroplasty as an alternative to laparoscopic sleeve gastrectomy.Author: yoon, jy.Et al.A meta-analysis of 1,772 patients reported a pooled rate of severe aes of 2.2% after esg.The reported aes were pain or nausea requiring hospitalization in 18 cases (1.08%), upper gastrointestinal (gi) bleeding in nine cases (0.56%), perigastric leak or collection in eight cases (0.48%), pulmonary embolism in one case (0.06%), and pneumoperitoneum in one case (0.06%).

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY; 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: 11603164
• MDR Text Key: 243661912
• Report Number: 3006722112-2021-00025
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention