MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

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

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

Initial medwatch submitted to the fda on 13/oct/2020 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.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 -abdominal pain and / or bloating -pharyngeal, colonic and/or esophageal perforation the labeling is adequate as it addresses the reported complaints.The occurrence of this reported complaint for this product will be reviewed as appropriate in the complaints analysis meeting (cam).

Event Description

Written as: there was one case of superficial esophageal tear from using the overtube with the overstitch device, which was controlled endoscopically without need for repeat procedure.

• 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: 10670220
• MDR Text Key: 211030939
• Report Number: 3006722112-2020-00096
• Device Sequence Number: 1
• Product Code: OCW
• 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: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• 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): Required Intervention