MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC SUTURING SYSTEM FOR ESS

Model Number	THX-165-028
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on 21/apr/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 "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 and 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.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 af05306 and allegation.
Event or Problem Description
The device got stuck in the patient and was cut to be removed but part of the device was still stuck and the patient had to be transported to a new hospital were the doctor was able to remove the rest of the helix.The patient was released the next day and is doing well.
Additional Manufacturer Narrative
Supplement #01 medwatch submitted to the fda on 14/jun/2023.Additional information: the investigator determined that a device history record (dhr) review is required for this complaint due to the complaint being vigilance or mdr reportable.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 af05306 and allegation.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 18/apr/2023.An ensizor, grasper, needle driver, anchor exchange and handle of the tissue helix returned.Engineering examined the devices prior to decontamination and did not find any discrepancies.The ensizor and grasper had no discrepancies.Engineering tested the needle driver, and it opens and closes as intended.Engineering visually inspected the needle driver and found a hole on the anchor exchange channel.There is also a small kink on the tissue helix channel at the distal end.Engineering inspected the tissue helix handle, and it locks and unlocks as intended.The wire inside the helix handle is assembled correctly.The complaint could not be verified as the devices that were returned had no discrepancies that could have contributed to the reported event.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: SUTURING SYSTEM FOR ESS
• Common Device Name: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA, SRL; coyol free zone; building b 13.3; alajuela, cs CRI ; CS CRI
• Manufacturer Contact: adriana russell ; 1120 s. captail of texas hwy; bldg 1, ste 300; austin 78746 ; 5122795114
• MDR Report Key: 16785648
• Report Number: 3006722112-2023-00077
• Device Sequence Number: 5691536
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(17)20251109(11)20221109(10)AF05306
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 03/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2025
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF05306
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: Male