MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH SUTURE CINCH

Model Number CNH-G01-000

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

The consumer reported they will not return the device.Therefore no analysis or testing will be done.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 cinch-deployment difficulty" as follows: note: it is the collar that sets the final position of the cinch, not the plug.Caution: the safety spacer must only be removed immediately prior to deploying cinch.Troubleshooting: cinch does not cut the suture when fired: use a suitable accessory through the secondary working channel to cut the suture and remove the cinch.Use standard endoscopic techniques to remove the cut suture.

Event Description

Reported complaint: "cinch broke, got stuck in patient, had to forcefully remove.".

Manufacturer Narrative

Supplement #1 - medwatch sent to the fda on (b)(6) 2020.Additional information: d4.

• Brand Name: OVERSTITCH SUTURE CINCH
• Type of Device: SUTURE CINCH
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9476733
• MDR Text Key: 180784694
• Report Number: 3006722112-2019-00201
• Device Sequence Number: 1
• Product Code: OCW
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF02998
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention