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

Model Number THX-165-028

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem Perforation (2001)

Event Date 02/10/2022

Event Type  malfunction  

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 Description

Helix perforation in stomach, was removed successfully.

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
• Type of Device: 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
• MDR Text Key: 287686953
• Report Number: 3006722112-2022-00027
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(17)20240924(11)20210924(10)AF04723
• 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: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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