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

Model Number THX-165-028

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

Combined medwatch submitted to the fda on (b)(6) 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 · 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.Dhr review was completed for lot number, af04791.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, af04791.Device evaluation summary: the device was returned to the apollo device analysis laboratory on 03/aug/2023.One tissue helix was returned for evaluation.Engineering visually and functionally tested the device.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 knob was rotated, and the coil turned as intended.There was no whipping of the wire.Under microscopic analysis, the helix tip appeared to be sharp.The complaint could not be verified as functional evaluation showed the device performed as intended.

Event Description

Healthcare professional reported difficulty removing helix from mucosa.Argon used for eventual removal and clips applied for closure.Procedure was aborted.Patient is doing well.

• 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: 17549930
• MDR Text Key: 321807377
• Report Number: 3006722112-2023-00154
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(17)20241115(11)20211115(10)AF04791
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF04791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female