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

Model Number CNH-C01-213-L

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/03/2023

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on 25/aug/2023.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 and suture cinch-handle broke during deployment" 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.Warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Note: it is the collar that sets the final position of the cinch, not the plug.Use standard endoscopic techniques to remove the cut suture.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint, as there was three other similar complaints against this lot number, af05330 and allegation.Dhr review was completed for lot number, af05330.The subject product met all specifications and requirements in effect at the time of manufacture.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 27/jul/2023.A cinch was returned with only the handle and the wire is broken at the handle.Under microscopic analysis, the wire in the handle is broken and the remaining wire was cut and removed.Due to the damaged device, a functional evaluation could not be conducted.The complaint was verified as the wire in the handle was broken which would signify that a malfunction occurred.Lab analysis was able to replicate the reported event of "suture cinch-deployment difficulty", as the wire is broken in the handle.The user effect of "suture cinch-deployment difficulty" is known and labeled possible adverse event.

Event Description

Cinch cut the suture but did not disengage from the device.Metal was pulled to dislodge resulting in removal of the sutures.Procedure successfully completed with competitive device.Patient is doing well.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
• Type of Device: SUTURE SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; bldg b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. capital of texas hwy; bldg. 1 ste. 300; austin, TX 78746 ; 5122795114
• MDR Report Key: 17622948
• MDR Text Key: 321935643
• Report Number: 3006722112-2023-00159
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020756
• UDI-Public: (01)10811955020756(17)20250104(11)20220104(10)AF05330
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNH-C01-213-L
• Device Catalogue Number: CNH-C01-213-L
• Device Lot Number: AF05330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2022
• 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 Sex: Female