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

Model Number	THX-165-028
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on 22/jun/2021.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
Device malfunctioned and became stuck in tissue causing a small perforation.
Additional Manufacturer Narrative
Supplement 01 medwatch submitted to the fda on 27/aug/2021.The device has not been returned for analysis.A device history record (dhr) review was performed as the lot number was provided and the device was not returned.The subject product met all specifications and requirements in effect at the time of manufacture.There are no other complaints against this lot number and issue, af03509.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX
• MDR Report Key: 12049930
• Report Number: 3006722112-2021-00052
• Device Sequence Number: 11865026
• Product Code: LTI
• UDI-Device Identifier: 10811955020688
• UDI-Public: (01)10811955020688(10)AF03509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03509
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention