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

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144); Gastrointestinal Hemorrhage (4476)

Event Type  malfunction  

Manufacturer Narrative

Additional information: the device has not been returned for analysis due to this being a literature review, and after multiple attempts to gather more information from the reporter, no additional information has been received.The investigator determined a device history record (dhr) review is not possible for this complaint, as attempts at gathering the device serial/lot number were unsuccessful.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 "suture assembly-suture broke during procedure; vessel damage / bleeding and multiple symptoms" ess - " 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.Note: ensure suture is not tangled after removal from the cartridge.Caution: do not use when valve covers are closed as suture drag will be increased.Caution: if resistance is encountered when advancing the anchor exchange through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly.Ensure that there is sufficient space for the needle to open.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint and product will be monitored as appropriate.

Event Description

This report is filed from an literature review where it was a review of several cases.This report is being filed for the following events: multiple symptoms and bleeding.

• 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
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs ; CS
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 12961607
• MDR Text Key: 285242280
• Report Number: 3006722112-2021-00116
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• 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): Required Intervention