MAUDE Adverse Event Report: APOLLO ENDOSURGERY INC. APOLLO OVER STITCH CINCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Catalog Number CNH-G-01-000

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, this patient underwent a colonoscopy with full-thickness esd excision/emr.The apollo suturing system was used to remove the polyp and after obtaining the polyp, the over stitch cinch device malfunctioned.This resulted in extensive intervention lasting approximately one hour to retrieve the suture.

• Brand Name: APOLLO OVER STITCH CINCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): APOLLO ENDOSURGERY INC.; 1120 s. capital of texas highway; bldg 1 - suite 300; austin TX 78764
• MDR Report Key: 9971936
• MDR Text Key: 188390530
• Report Number: MW5094176
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Catalogue Number: CNH-G-01-000
• Device Lot Number: AF03255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 117