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

Model Number CNH-G01-000

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2022

Event Type  malfunction  

Event Description

Handle broke during deployment causing the metal wire to lodge in the patient anatomy.The suture and wire were removed successfully.

Manufacturer Narrative

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.The labeling is adequate as it addresses the reported complaint.The occurrence of this reported complaint and product will be monitored as appropriate.Additional information: the device has not been returned for analysis.The investigator determined that a device history record (dhr) review is not required for this complaint, as there are no other complaints against this lot number, af04693.

Manufacturer Narrative

Supplement #x medwatch submitted to the fda on 27/jun/2022.A device history record (dhr) review was performed for reporting purposes.The subject product met all specifications and requirements in effect at the time of manufacture.There were no other complaints in the apollo database against this lot number, af04693.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 27/apr/2022.The suture cinch was returned dismantled.The distal components and heat shrink are present.Engineering visually inspected the device prior to decontamination and found no visible manufacturing defects.The plug, collar and plunger are present and there were no discrepancies with the indent.Engineering performed additional analysis of the device.The components were dissected, and no manufacturing abnormalities observed.A sample cinch was tested to try and recreate the failure.When the handle was over squeezed, the suture broke, and the same failure was observed.The complaint could not be verified as visual inspection of the device did not show any manufacturing defects.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING 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; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746 ; 5128523757
• MDR Report Key: 14316259
• MDR Text Key: 294771277
• Report Number: 3006722112-2022-00042
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020671
• UDI-Public: (01)10811955020671(17)20240820(11)20210820(10)
• 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,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CNH-G01-000
• Device Catalogue Number: CNH-G01-000
• Device Lot Number: AF04693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2021
• 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