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

Model Number	THX-165-028
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial medwatch submitted to the fda.The reporter of the event was asked to return the product for analysis.To date, apollo has not received the device.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.
Event or Problem Description
Reported as: "the device stays stuck in the wall of the patient's stomach.Impossible to remove.Risk of tear.".

• Brand Name: OVERSTITCH¿ ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: ENDOSCOPIC SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 9606964
• Report Number: 3006722112-2020-00007
• Device Sequence Number: 524328
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

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 Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF02904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 104