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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

Initial medwatch submitted to the fda on 19may2023.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 investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being mdr reportable.

Event Description

Helix screwed into tissue then would not unscrew from tissue.Helix was removed utilizing small cuts to release from tissue.Procedure was postponed.Patient is doing fine.

Manufacturer Narrative

Supplement #01 medwatch submitted to the fda on 13/jul/2023.Additional information: the investigator determined that a device history record (dhr) review was required for this complaint due to the complaint being reportable.A previous dhr review was completed for lot number, af05123.The subject product met all specifications and requirements in effect at the time of manufacture.There was one other complaint in the apollo database against this lot number.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 26/june/2023.One tissue helix was returned for investigation.Under microscopic analysis, the helix tip appeared to be sharp.Engineering functionally tested the device and during rotation of the knob, the coil rotated as intended.The knob was pushed down, and it extended the coil as intended, then the knob was pulled up and the coil retracted into the catheter as intended.The complaint could not be verified as the returned tissue helix functionally performed as intended.Lab analysis was not able to replicate the reported event of "helix-could not be removed from tissue".It has not been possible to determine a root cause for this reported complaint.The user effect of "helix-could not be removed from tissue" is known and labeled possible adverse event.

• 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; 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: 16961464
• MDR Text Key: 315563984
• Report Number: 3006722112-2023-00090
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(17)20250623(11)20220623(10)AF05123
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: AF05123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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 Age: 38 YR
• Patient Sex: Female