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 Codes	Perforation (2001); Insufficient Information (4580)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial medwatch submitted to the fda on (b)(6) 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-did not turn properly" as follows: warnings: only physicians possessing sufficient skill and experience in similar, or the same techniques should perform endoscopic procedures.Caution: if resistance is encountered when advancing the helix through the working channel of the endoscope, reduce the endoscope angulation until the device passes smoothly, and ensure that the secondary working channel is not obstructed on the endoscope.Caution: do not depress helix handle button while advancing helix through endoscope.The labeling is adequate as it addresses the reported complaint.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 with possible perforation of the stomach, patient was admitted for observation.

• 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: 11924737
• Report Number: 3006722112-2021-00043
• Device Sequence Number: 11871998
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2022
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/02/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 103