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

Model Number	THX-165-028
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on 08/mar/2022.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 "helix-could not be removed from tissue" as follows: warnings: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Troubleshooting: helix stuck in tissue: i.Use a suitable accessory through the primary channel to apply counter traction to the tissue around the helix, and pull the helix free.Ii.Once endoscopic techniques have been exhausted, utilize laparoscopic techniques to remove the helix.Adverse events: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: conversion to laparoscopic or open procedure.Intra-abdominal (hollow or solid) visceral injury.Additional information: the device has not been returned for analysis.A device history record (dhr) review is pending for reporting purposes.There were no other complaints in the apollo database against this lot number, af04723.
Event or Problem Description
Helix perforation in stomach, was removed successfully.
Additional Manufacturer Narrative
Supplement #x medwatch submitted to the fda on 04/may/2022.Additional information: 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, af04723.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 25/feb/2022.A tissue helix and two needle drivers were returned.There is tissue/blood present on the tissue helix.There is significant damage to the helix channel on the sx device.Prior to decontamination engineering did a preliminary investigation and found that the tip of the helix is sharp.The helix rotates in both directions and retracts as intended.There is damage to the sheath on the helix from the removal of the device.After decontamination, the helix was mated to the helix crimp tube via a circumferential laser weld; the crimp tube was then crimped to the helix control wire.The control wire transmitted torque to drive the helix end effector into and out of tissue and the wire did not slip or spin inside the tube.The complaint could not be verified as the returned tissue helix functionally performed as intended.The damage that the helix channel sustained was due to removal of the tissue helix.

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: 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, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• Manufacturer Contact: david hooper ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin, TX 78746
• MDR Report Key: 13693434
• Report Number: 3006722112-2022-00027
• Device Sequence Number: 19309312
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(17)20240924(11)20210924(10)AF04723
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K081853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2024
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF04723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female