MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERSTITCH ENDOSCOPIC SUTURING SYSTEM; ENDOSCOPIC SUTURING UNIT

Model Number	THX-165-028
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the apollo device analysis laboratory on 05/nov/2020.Analysis of the device is ongoing.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
Difficulties in removing the helix from the tissue.
Additional Manufacturer Narrative
Supplement #1 medwatch submitted to the fda on 09/feb/2021.Device evaluation summary: the device was returned to the apollo device analysis laboratory on (b)(6) 2020.One tissue helix was returned with blood/tissue present on the distal end of the coil catheter inside the sheath.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.During rotation of the knob, the turning knob would stick and become intermittent on rotation.Under microscopic analysis, tissue remnant and brown particulate matter was observed on the control wire, helix crimp tube, and corkscrew-helix.A portion of the brown particulate matter and tissue remnant was cleaned from the end of the corkscrew-helix and the helix tip appeared to be sharp.The complaint was verified as functional evaluation showed the rotation knob was difficult to turn.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Common Device Name: ENDOSCOPIC SUTURING UNIT
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• MDR Report Key: 10871826
• Report Number: 3006722112-2020-00113
• Device Sequence Number: 3006048
• Product Code: OCW
• UDI-Device Identifier: 10811955020688
• UDI-Public: 10811955020688
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/15/2021

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 Expiration Date: 01/21/2023
• Device Model Number: THX-165-028
• Device Catalogue Number: THX-165-028
• Device Lot Number: AF03617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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
• Patient Age: 43 YR
• Patient Weight: 97